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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00536 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-0586 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies the side effects and best dose of radiation therapy in patients with brain tumors that have come back after previous treatment with radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in different ways may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To estimate the rate of grade 3 or higher central nervous system (CNS) necrosis 6 months after reirradiation of the brain for recurrent tumor.
SECONDARY OBJECTIVES:
I. To evaluate acute and late toxicities of reirradiation. II. To evaluate longitudinal changes in symptom burden of patients undergoing reirradiation.
III. To use Advanced Brain Tumor Imaging (ABTI) to evaluate changes in the brain after reirradiation, including progression, pseudoprogression, and radionecrosis.
IV. To estimate progression-free survival (PFS) and overall survival (OS) following reirradiation.
OUTLINE: Patients are assigned to 1 of 2 arms based on age.
ARM I (Age 0-18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
ARM II (Age > 18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, then every 2 months for 1 year, then every 3 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (conventional fractionation) | Experimental | Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. |
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| Arm II (conventional fractionation, bevacizumab) | Active Comparator | Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Highest grade of central nervous system (CNS) necrosis | The outcome will be categorized as (death within 6 months), (alive at month 6 with necrosis), (alive at month 6 without necrosis). The probabilities of these outcomes will be estimated using 95% posterior credible intervals assuming a Dirichlet (.33, .33, .33) prior. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute and late toxicities | Up to 3.5 years | |
| Overall survival (OS) time | Will be estimated by Kaplan-Meier method, and the relationship of OS to baseline covariates will be evaluated by Bayesian survival time regression. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom burden | Will be measured by MDASI-BT questionnaire in adults and PROMIS short forms in children. | Up to 3.5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan L McGovern | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D007074 | Immunoglobulin G |
| D004220 | Disulfides |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Radiation Therapy | Radiation | Undergo radiation therapy with conventional fractionation |
|
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| Up to 3.5 years |
| Progression-free survival (PFS) time | Will be estimated by Kaplan-Meier method, and the relationship of PFS to baseline covariates will be evaluated by Bayesian survival time regression. | Up to 3.5 years |
| Quality of life | Will be assessed using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and patient-reported outcomes measurement information system (PROMIS) instrument. | Up to 3.5 years |
| Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI) | Up to 3.5 years |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007132 | Immunoglobulin Isotypes |
| D013440 | Sulfides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006862 | Hydrogen Sulfide |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |