| Primary | 3-year Event-Free Survival Probability | The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame. | | Posted | | Number | 95% Confidence Interval | probability | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | Stanford V Chemotherapy | Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.887(0.821 to 0.959)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The association of age with EFS was compared. P values from Score test were computed for the statistical significance. | Cox Model | | 0.9970 | | | | | | | | | | | | | | Superiority or Other (legacy) | | |
|
| Secondary | Disease Failure Rate Within Radiation Fields | Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). | | Posted | | Number | 95% Confidence Interval | proportion of participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | Stanford V Chemotherapy | Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
| |
| Secondary | Local and Distant Failure for Children Treated With Tailored-field Radiation | The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field. | | Posted | | Number | 95% Confidence Interval | probability that the event occurs | | from first enrollment date up to 3 years follow-up | | | | ID | Title | Description |
|---|
| OG000 | Stanford V Chemotherapy | Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
| |
| Secondary | Prognostic Factors for Treatment Failure: Age | Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. | | Posted | | Number | | events | | 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up | | | | ID | Title | Description |
|---|
| OG000 | Stanford V Chemotherapy | Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
| |
| Secondary | Patient Quality of Life (QoL), PedsQL v.4.0: Total Score | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Total Score | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Nausea | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Worry | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), PedsQL v.3.0: Communication | Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Patient Quality of Life (QoL), Symptom Distress Scale | The patient's degree of discomfort from specific treatment-related symptoms across multiple time points. Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 | After Radiation |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | | OG003 |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication | Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Week 12 | Evaluation completed following 4 courses of therapy, approximately week 16 after start. | |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 | |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 | |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 | |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 | |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 | |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 | |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 |
|
| Secondary | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication | Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy. | Posted | | Mean | Standard Deviation | units on a scale | | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | Parent and Patient Scores at Pre-therapy | Evaluation completed prior to the start of treatment. | | OG001 | Parent and Patient Scores at Week 8 | Evaluation completed following 2 courses of therapy, approximately week 8 after start. | | OG002 | Parent and Patient Scores at Week 12 |
|
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score | Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning | Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health | Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning | Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning | Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning | Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication | Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50. | Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions. | Posted | | Number | 95% Confidence Interval | beta coefficient | | 6 months after the completion of therapy | | | | ID | Title | Description |
|---|
| OG000 | QoL Participants | All participants who completed the required questionnaires during at least one time point for evaluating this outcome. |
| |
| Secondary | 3-year Event-free Survival (EFS) Probability | Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. | | Posted | | Number | 95% Confidence Interval | probability | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | HOD05 Participants | Current study defined as Intermediate Risk single arm classified as:
- EITHER Ann Arbor stage IB and IIIA,
- OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. | | OG001 | HOD99 Participants | Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:
- EITHER Ann Arbor stage IB and IIIA,
- OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine. |
|
| Secondary | 3-year Overall Survival (OS) Probability | Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. | | Posted | | Number | 95% Confidence Interval | probability | | 3-years | | | | ID | Title | Description |
|---|
| OG000 | HOD05 Participants | Current study defined as Intermediate Risk single arm classified as:
- EITHER Ann Arbor stage IB and IIIA,
- OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. | | OG001 | HOD99 Participants | Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as: EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph). Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine. |
|
| Secondary | 3-year Local Failure-free Survival Probability | Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. | | Posted | | Number | 95% Confidence Interval | probability | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | HOD05 Participants | Current study defined as Intermediate Risk single arm classified as:
- EITHER Ann Arbor stage IB and IIIA,
- OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. | | OG001 | HOD99 Participants | Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as: EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph). Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine. |
|
| Secondary | Toxicities With Grade >1 | Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date. | Posted | | Number | | adverse events | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | HOD05 - Grade 2 | Participants in current study. | | OG001 | HOD05 - Grade 3 | Participants in current study. | | OG002 | HOD05 - Grade 4 | Participants in current study. | | OG003 | HOD05 - Grade 5 | Participants in current study. |
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| Secondary | Prognostic Factors for Treatment Failure: Gender | Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. | | Posted | | Number | | events | | 3 years follow-up | | | | ID | Title | Description |
|---|
| OG000 | Stanford V Chemotherapy | Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
| |
| Secondary | Prognostic Factors for Treatment Failure: Histology | Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. | | Posted | | Number | | events | | 3 years follow-up | | | | ID | Title | Description |
|---|
| OG000 | Stanford V Chemotherapy | Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
| |
| Secondary | Prognostic Factors for Treatment Failure: Stage | Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage \ | | Posted | | Number | | events | | 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up | | | | ID | Title | Description |
|---|
| OG000 | Stanford V Chemotherapy | Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy. |
| |
| Secondary | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram) | Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized. | At each time point, a participant underwent an Echocardiogram (ECHO). Data was unavailable for patients who did not undergo the Echocardiogram at that time point. | Posted | | Count of Participants | | Participants | | 1, 2, 5, and 10 years post therapy | | | | ID | Title | Description |
|---|
| OG000 | Year 1 Off Therapy | Evaluation completed approximately 1 year following completion of therapy. | | OG001 | Year 2 Off Therapy | Evaluation completed approximately 2 years following completion of therapy. | | OG002 | Year 5 Off Therapy | Evaluation completed approximately 5 years following completion of therapy. | | OG003 | Year 10 Off Therapy | Evaluation completed approximately 10 years following completion of therapy. |
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| Secondary | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram) | Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome. | At each time point, a participant underwent an Electrocardiogram (EKG). Data was unavailable for patients who did not undergo the Electrocardiogram at that time point. | Posted | | Count of Participants | | Participants | | 1, 2, 5, and 10 years post therapy | | | | ID | Title | Description |
|---|
| OG000 | Year 1 Off Therapy | Evaluation completed approximately 1 year following completion of therapy. | | OG001 | Year 2 Off Therapy | Evaluation completed approximately 2 years following completion of therapy. | | OG002 | Year 5 Off Therapy | Evaluation completed approximately 5 years following completion of therapy. | | OG003 | Year 10 Off Therapy | Evaluation completed approximately 10 years following completion of therapy. |
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| Secondary | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function) | Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results. | At each time point, participants who received mediastinal/lung radiation or bleomycin underwent pulmonary function (PFT) assessment. Data was unavailable for patients who did not undergo the pulmonary function test at that time point. | Posted | | Count of Participants | | Participants | | 1, 2, 5, and 10 years post therapy | | | | ID | Title | Description |
|---|
| OG000 | Year 1 Off Therapy | Evaluation completed approximately 1 year following completion of therapy. | | OG001 | Year 2 Off Therapy | Evaluation completed approximately 2 years following completion of therapy. | | OG002 | Year 5 Off Therapy | Evaluation completed approximately 5 years following completion of therapy. | | OG003 | Year 10 Off Therapy | |
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| Secondary | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) | For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings. | At each time point, participants who received cervical and upper mediastinal radiation underwent TSH laboratory test. Data was unavailable for patients who did not undergo the TSH test at that time point. | Posted | | Count of Participants | | Participants | | 1, 2, 5, and 10 years post therapy | | | | ID | Title | Description |
|---|
| OG000 | Year 1 Off Therapy | Evaluation completed approximately 1 year following completion of therapy. | | OG001 | Year 2 Off Therapy | Evaluation completed approximately 2 years following completion of therapy. | | OG002 | Year 5 Off Therapy | Evaluation completed approximately 5 years following completion of therapy. | | OG003 | Year 10 Off Therapy | |
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