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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03721 | Registry Identifier | NCI Clinical Trial Registration Program |
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With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.
This study will evaluate the following objectives:
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unfavorable Risk, Group 2 | Experimental | Unfavorable risk, group 2 arm in patients with Hodgkin's disease (n=146) |
|
| Favorable Risk | Experimental | Favorable Risk arm in patients with Hodgkin's Disease (n=91). |
|
| Intermediate Risk | Experimental | Intermediate Arm in patients with Hodgkins's disease (n=46). |
|
| Unfavorable Risk, Group 1 | Experimental | Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 Week Stanford V Chemotherapy | Drug | 12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival Probability by Risk Group | Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula. | Median 6.4 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival Probability by Risk Group at 10-year Follow-Up | Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the with Greenwood's formula. |
Inclusion Criteria:
Inclusion: treatment of favorable risk features:
Ann Arbor IA or IIA with:
Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x ray)
Ann Arbor stage IA or IIA with any of the following features: (1) "E" lesions (s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Inclusion: unfavorable risk features:
Stage must be classified as one of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Flerlage, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Maine Children's Cancer Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22735430 | Derived | Metzger ML, Weinstein HJ, Hudson MM, Billett AL, Larsen EC, Friedmann A, Howard SC, Donaldson SS, Krasin MJ, Kun LE, Marcus KJ, Yock TI, Tarbell N, Billups CA, Wu J, Link MP. Association between radiotherapy vs no radiotherapy based on early response to VAMP chemotherapy and survival among children with favorable-risk Hodgkin lymphoma. JAMA. 2012 Jun 27;307(24):2609-16. doi: 10.1001/jama.2012.5847. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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296 patients were enrolled from 5 institutions between March 2000 and May 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Favorable Risk | Ann Arbor stage IA or IIA with:
|
| FG001 | Intermediate Risk | Stage must be classified as one of the following:
|
| FG002 | Unfavorable Risk, Group 1 | Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13). |
| FG003 | Unfavorable Risk, Group 2 | Stage must be classified as one of the following: a. Ann Arbor stage IIB, IIIB, or any IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Favorable Risk | Ann Arbor stage IA or IIA with:
|
| BG001 | Intermediate Risk |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event-free Survival Probability by Risk Group | Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula. | Nine patients were ineligible for analysis. | Posted | Number | 95% Confidence Interval | probability of 5 yr. event free survival | Median 6.4 year follow-up |
|
Adverse events were collected from the date a patient went on study through the completion of therapy. The elapsed timeframe for adverse event collection was eleven years (March, 2000 through May, 2011).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Favorable Risk | Ann Arbor stage IA or IIA with:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Flerlage, MD | St. Jude Children's Research Hospital | 1-866-278-5833 | info@stjude.org |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| 4 cycles of VAMP chemotherapy | Drug | 4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy. |
|
| 2 alternating cycles of VAMP/COP chemotherapy | Drug | 2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT. |
|
| 3 alternating cycles of VAMP/COP chemotherapy | Drug | 3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT |
|
| At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
| Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
| Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
| Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
| Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
| Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
| Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
| Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
| 10-year follow-up after protocol enrollment |
| Portland |
| Maine |
| 04102-3175 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Clinical Trials Open at St. Jude | View source |
| Ineligible |
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| Lost to Follow-up |
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| Noncompliance |
|
| Withdrawal by Subject |
|
Stage must be classified as one of the following:
|
| BG002 | Unfavorable Risk, Group 1 | Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13). |
| BG003 | Unfavorable Risk, Group 2 | Stage must be classified as one of the following: a. Ann Arbor stage IIB, IIIB, or any IV |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Intermediate Risk | Stage must be classified as one of the following:
|
| OG002 | Unfavorable Risk, Group 1 | Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13). |
| OG003 | Unfavorable Risk, Group 2 | Stage must be classified as one of the following: a. Ann Arbor stage IIB, IIIB, or any IV |
|
|
|
| Secondary | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have 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), and 3-6 months after the completion of therapy (T5). |
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| Secondary | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have 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), and 3-6 months after the completion of therapy (T5). |
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| Secondary | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have 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), and 3-6 months after the completion of therapy (T5). |
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| Secondary | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have 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), and 3-6 months after the completion of therapy (T5). |
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| Secondary | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have 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), and 3-6 months after the completion of therapy (T5). |
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| Secondary | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have 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), and 3-6 months after the completion of therapy (T5). |
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| Secondary | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). |
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| Secondary | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Secondary | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Secondary | Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Secondary | Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Secondary | Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Secondary | Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Secondary | Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Secondary | Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. | Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month. | Posted | Mean | Standard Deviation | units on a scale | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) |
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| Other Pre-specified | Event-free Survival Probability by Risk Group at 10-year Follow-Up | Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the with Greenwood's formula. | Nine patients were ineligible for analysis. | Posted | Number | 95% Confidence Interval | probability 10 yr. event free survival | 10-year follow-up after protocol enrollment |
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| 0 |
| 91 |
| 54 |
| 88 |
| EG001 | Intermediate Risk | Stage must be classified as one of the following:
| 0 | 46 | 39 | 46 |
| EG002 | Unfavorable Risk, Group 1 | Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13). | 0 | 13 | 12 | 13 |
| EG003 | Unfavorable Risk, Group 2 | Stage must be classified as one of the following: a. Ann Arbor stage IIB, IIIB, or any IV | 1 | 146 | 116 | 146 |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mucositis/stomatitis (functional/symptomatic), Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC<1.0x10e | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Infection with unknown ANC, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Spearman Correlation Coefficients |
| 0.60 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | <0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.50 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | <0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.37 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0197 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.51 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.46 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.41 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | <0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.42 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.3624 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.52 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.44 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0004 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | 0.0001 | Spearman Correlation Coefficients | 0.32 | 95 | Superiority or Other (legacy) |
| Wilcoxon Correlation Coefficients | <0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.39 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0014 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | 0.0061 | Spearman Correlation Coefficients | 0.26 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.65 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.9478 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.42 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.2999 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.49 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.3121 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.52 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.57 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0282 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | 0.0002 | Spearman Correlation Coefficients | 0.35 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0038 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.43 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.1474 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.49 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.63 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0050 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.45 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0005 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | 0.0001 | Spearman Correlation Coefficients | 0.37 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0552 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.54 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.53 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxan signed rank test | <0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.68 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0017 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.50 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.60 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.1731 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.60 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0846 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.46 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.51 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | <0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.54 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0468 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.55 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.26 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | <0.0001 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | 0.0704 | Spearman Correlation Coefficients | 0.16 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0200 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.42 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.42 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.8663 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.41 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.7626 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.58 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.36 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0824 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.39 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0496 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.50 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.37 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0014 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.43 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.1478 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.56 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.25 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0135 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | 0.0024 | Spearman Correlation Coefficients | 0.27 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.9848 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | 0.0974 | Spearman Correlation Coefficients | 0.16 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients |
| 0.43 |
| 95 |
| Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.0012 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.54 | 95 | Superiority or Other (legacy) |
| Wilcoxon signed rank test | 0.8108 | 95 | Superiority or Other (legacy) |
| Spearman Correlation Coefficients | <0.0001 | Spearman Correlation Coefficients | 0.55 | 95 | Superiority or Other (legacy) |
| KM event-free survival estimate |
| 0.844 |
| 2-Sided |
| 95 |
| 0.739 |
| 0.950 |
| Superiority or Other (legacy) |
| KM event-free survival estimate | 0.667 | 2-Sided | 95 | 0.400 | 0.933 | Superiority or Other (legacy) |
| KM event-free survival estimate | 0.785 | 2-Sided | 95 | 0.716 | 0.853 | Superiority or Other (legacy) |