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| ID | Type | Description | Link |
|---|---|---|---|
| SU-04202010-5726 | Other Identifier | Stanford University | |
| BRN0012 | Other Identifier | OnCore | |
| IRB-17774 | Other Identifier | Stanford IRB |
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The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide
Primary Objective: To determine the maximum tolerated dose (MTD), based on acute CNS toxicity at 30 days, of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme.
Secondary Objectives:
To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
|
| Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
|
| Stereotactic Radiosurgery (35 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
|
| Stereotactic Radiosurgery (40 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose-limiting Toxicities (DLTs) | The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either:
Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity [Common Terminology Criteria for Adverse Events (CTCAE) v4] occurring within 30 days of stereotactic radiosurgery (SRS). The non-stratified outcome is reported as the number of DLTs observed in by radiation dose and by strata (Planning Target Volume (PTV) < 60 cm³ and from 60 to 150 cm³). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Acute Toxicity Within 30 Days | Acute toxicity is defined as treatment-related adverse events that occur within 30 days of receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each radiotherapy dose level. Acute toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Gerard Soltys, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2015 |
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Dose-escalation with 2-level stratification
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|
| Stereotactic Radiosurgery (SRS) | Procedure | Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
|
|
| 30 days |
| Long-term Toxicity After More Than 30 Days | Long-term toxicity is defined as treatment-related adverse events (any grade or any Body System) that occur ≥ 30 days after receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each dose level. Long-term toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only. | 12 months |
| Percent of Participants With Radiographic Response | Radiographic response rate was assessed following radiotherapy until disease progression. Response is considered to be the sum and proportion participants that achieved a complete response (CR); partial response (PR); or minor response (MR). The outcome is expressed as a number without dispersion for each cohort. CR: Tumor is no longer detected by computed tomography (CT) or magnetic resonance imaging (MRI). PR: Decrease in the product of the two greatest diameters > 50%, as determined by CT or MRI, with no new lesions, and the same or lower dose of dexamethasone. MR: Decrease in the product of the two greatest diameters < 50%, as determined by CT or MRI, and neither PR nor PD. PD: New tumor lesion, or > 25% increase in the product of the two greatest diameters of target lesion, as determined by CT or MRI, provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation. | 6 months |
| Progression-free Survival | Progression-free survival (PFS) following radiotherapy, measured in months. Progressive disease (PD) is defined as: New tumor lesion, or > 25% increase in the product of the 2 greatest diameters of target lesion, as determined by computed tomography (CT) or magnetic resonance imaging (MRI), provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation. The outcome is expressed as the median with 95% confidence interval for each cohort. | 18 Months. |
| Overall Survival (OS) | Overall survival (OS) was assessed as those participants remaining alive with any tumor status following radiotherapy after 20 months. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the median value with 95% confidence interval. | 20 Months. |
| Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey | European Organization for Research and Treatment of Cancer (EORTC-QLQ C30) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The EORTC-QLQ C30 survey has 30 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" and 4 indicating "very much". The total score can range from 30 to 120. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and is expressed as the mean of the difference from baseline to 12 months, with 95% confidence interval. | 12 Months |
| Quality of Life by Brain-20 Survey | Brain-20 (BN-20) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The Brain-20 (BN-20) quality of life survey has 20 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" (most favorable) and 4 indicating "very much" (least favorable). The total score can range from 20 to 80, and the result is expressed as the difference from baseline (study entry) to 12 months after the start of treatment. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean with 95% confidence interval. | 12 months |
| Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey | MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). MDASI-BT quality of life survey has 23 questions and responses are on scale of 0 to 10 with 0 indicating "did not interfere" (most favorable) and 10 indicating "interfered completely" (least favorable). A participant's overall score is computed as the mean of that participant's individual scores, and can range 0 to 10. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean difference from baseline with 95% confidence interval. A positive value for the mean indicates worsening quality of life. | 12 months |
| Treatment Failure Analysis | Treatment failure in individual participants, ie, tumor recurrence or metastasis, can be described by the location relative to the first treatment failure (ie, infield, marginal, or distal), as further defined below. Failure pattern is defined as tumor recurrence or metastasis relative to the primary lesion that is
The outcome will be reported as the number of participants who failed treatment for each type of failure, ie, infield, marginal, or distal failure. | 18 months |
| FG001 | Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| FG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| FG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| BG001 | Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| BG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| BG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Dose-limiting Toxicities (DLTs) | The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either:
Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity [Common Terminology Criteria for Adverse Events (CTCAE) v4] occurring within 30 days of stereotactic radiosurgery (SRS). The non-stratified outcome is reported as the number of DLTs observed in by radiation dose and by strata (Planning Target Volume (PTV) < 60 cm³ and from 60 to 150 cm³). | Participants receiving each radiotherapy level were stratified by tumor size. | Posted | Number | Number of DLT observed | 30 days |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Acute Toxicity Within 30 Days | Acute toxicity is defined as treatment-related adverse events that occur within 30 days of receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each radiotherapy dose level. Acute toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only. | Posted | Number | adverse events | 30 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Long-term Toxicity After More Than 30 Days | Long-term toxicity is defined as treatment-related adverse events (any grade or any Body System) that occur ≥ 30 days after receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each dose level. Long-term toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only. | Posted | Number | Number of adverse events | 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Radiographic Response | Radiographic response rate was assessed following radiotherapy until disease progression. Response is considered to be the sum and proportion participants that achieved a complete response (CR); partial response (PR); or minor response (MR). The outcome is expressed as a number without dispersion for each cohort. CR: Tumor is no longer detected by computed tomography (CT) or magnetic resonance imaging (MRI). PR: Decrease in the product of the two greatest diameters > 50%, as determined by CT or MRI, with no new lesions, and the same or lower dose of dexamethasone. MR: Decrease in the product of the two greatest diameters < 50%, as determined by CT or MRI, and neither PR nor PD. PD: New tumor lesion, or > 25% increase in the product of the two greatest diameters of target lesion, as determined by CT or MRI, provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation. | Posted | Number | Percentage of participants | 6 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival (PFS) following radiotherapy, measured in months. Progressive disease (PD) is defined as: New tumor lesion, or > 25% increase in the product of the 2 greatest diameters of target lesion, as determined by computed tomography (CT) or magnetic resonance imaging (MRI), provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation. The outcome is expressed as the median with 95% confidence interval for each cohort. | Participants who have not progresses and have not reached reached 18 months post-treatment are not included. | Posted | Median | 95% Confidence Interval | Months | 18 Months. |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) was assessed as those participants remaining alive with any tumor status following radiotherapy after 20 months. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the median value with 95% confidence interval. | Posted | Median | 95% Confidence Interval | Months | 20 Months. |
| ||||||||||||||||||||||||||||||||
| Secondary | Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey | European Organization for Research and Treatment of Cancer (EORTC-QLQ C30) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The EORTC-QLQ C30 survey has 30 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" and 4 indicating "very much". The total score can range from 30 to 120. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and is expressed as the mean of the difference from baseline to 12 months, with 95% confidence interval. | Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 Months |
| |||||||||||||||||||||||||||||||
| Secondary | Quality of Life by Brain-20 Survey | Brain-20 (BN-20) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The Brain-20 (BN-20) quality of life survey has 20 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" (most favorable) and 4 indicating "very much" (least favorable). The total score can range from 20 to 80, and the result is expressed as the difference from baseline (study entry) to 12 months after the start of treatment. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean with 95% confidence interval. | Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey | MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). MDASI-BT quality of life survey has 23 questions and responses are on scale of 0 to 10 with 0 indicating "did not interfere" (most favorable) and 10 indicating "interfered completely" (least favorable). A participant's overall score is computed as the mean of that participant's individual scores, and can range 0 to 10. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean difference from baseline with 95% confidence interval. A positive value for the mean indicates worsening quality of life. | Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Treatment Failure Analysis | Treatment failure in individual participants, ie, tumor recurrence or metastasis, can be described by the location relative to the first treatment failure (ie, infield, marginal, or distal), as further defined below. Failure pattern is defined as tumor recurrence or metastasis relative to the primary lesion that is
The outcome will be reported as the number of participants who failed treatment for each type of failure, ie, infield, marginal, or distal failure. | If the location of a participant's 1st treatment failure could not be determined, then a location assessment relative to any 2nd treatment failure can not done (null result), and for this reason, this analysis only includes participants for whom the location of the 1st treatment failure could be determined. | Posted | Count of Participants | Participants | 18 months |
|
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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 | Stereotactic Radiosurgery (25 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) | 6 | 6 | 6 | 6 | 6 | 6 |
| EG001 | Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) | 5 | 6 | 6 | 6 | 5 | 6 |
| EG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) | 4 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) | 10 | 12 | 9 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders-Other, altered mental state | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE v4 | Systematic Assessment |
| |
| Edema cerebral | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE v4 | Systematic Assessment |
| |
| Surgical and medical procedures - Other, ressection of recurrent tumor | Surgical and medical procedures | CTCAE v4 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nervous system disorders -Other, necrosis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nervous system disorders -Other, aphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Soltys (Associate Professor of Radiation Oncology) | Stanford University | 650-724-1569 | sgsoltys@stanford.edu |
| Jan 31, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| Planning Target Volume (PTV) 60 to 150 cm³ |
|
|
| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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| Stereotactic Radiosurgery (30 Gray x 5 Fractions)+Temozolomide |
Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.
Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
| OG002 | Stereotactic Radiosurgery (35 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
| OG003 | Stereotactic Radiosurgery (40 Gray x 5 Fractions)+Temozolomide | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Temozolomide: 75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. Stereotactic Radiosurgery (SRS): Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) |
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