Radiation Therapy in Treating Patients With Recurrent Brain Tumors Who Have Undergone Previous Radiation Therapy
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| ClinicalTrials.gov Identifier: NCT02698254 |
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Recruitment Status :
Recruiting
First Posted : March 3, 2016
Last Update Posted : January 7, 2021
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Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Brain Neoplasm | Biological: Bevacizumab Other: Quality-of-Life Assessment Radiation: Radiation Therapy | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors |
| Actual Study Start Date : | July 20, 2016 |
| Estimated Primary Completion Date : | July 1, 2022 |
| Estimated Study Completion Date : | July 1, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Brain Tumors
Drug Information available for:
Bevacizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I (conventional fractionation)
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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Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment Radiation: Radiation Therapy Undergo radiation therapy with conventional fractionation
Other Names:
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Active Comparator: Arm II (conventional fractionation, bevacizumab)
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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Biological: Bevacizumab
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Radiation: Radiation Therapy Undergo radiation therapy with conventional fractionation
Other Names:
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Primary Outcome Measures :
- Highest grade of central nervous system (CNS) necrosis [ Time Frame: At 6 months ]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.
Secondary Outcome Measures :
- Incidence of acute and late toxicities [ Time Frame: Up to 3.5 years ]
- Overall survival (OS) time [ Time Frame: Up to 3.5 years ]Will be estimated by Kaplan-Meier method, and the relationship of OS to baseline covariates will be evaluated by Bayesian survival time regression.
- Progression-free survival (PFS) time [ Time Frame: Up to 3.5 years ]Will be estimated by Kaplan-Meier method, and the relationship of PFS to baseline covariates will be evaluated by Bayesian survival time regression.
- Quality of life [ Time Frame: Up to 3.5 years ]Will be assessed using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and patient-reported outcomes measurement information system (PROMIS) instrument.
- Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI) [ Time Frame: Up to 3.5 years ]
Other Outcome Measures:
- Symptom burden [ Time Frame: Up to 3.5 years ]Will be measured by MDASI-BT questionnaire in adults and PROMIS short forms in children.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Previous pathologic confirmation of a tumor treated with radiation to the brain completed at least 6 months prior to the start of planned reirradiation, except for patients with tumors that are routinely diagnosed without biopsy, including germinoma and optic pathway glioma; patients with a history of cranial irradiation for leukemia are eligible
- Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day
- Multidisciplinary evaluation of the patient must be performed with a consensus recommendation for reirradiation
- Patient may not receive concurrent chemotherapy with reirradiation, other than temozolomide or bevacizumab given at the discretion of the treating neuro-oncologist
- Patient must have imaging findings within the last 3 months consistent with recurrent disease in the brain; pathologic diagnosis of recurrence is not required
- Patient may undergo surgical resection prior to reirradiation
- Dose-volume histogram data and cross-sectional imaging from previous radiation must be obtained; electronic dosimetry records in Digital Imaging and Communications in Medicine (DICOM) format from previous radiation are strongly preferred
- Signed informed consent by patient and/or parents or legal guardian
- Lansky/Karnofsky performance status score of 50-100
Exclusion Criteria:
- Patients with recurrent diffuse intrinsic pontine glioma (DIPG)
- Pregnancy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698254
Contacts
| Contact: Susan L. McGovern, MD, PHD | 713-563-2300 | slmcgove@mdanderson.org |
Locations
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Susan L. McGovern 713-563-2300 | |
| Principal Investigator: Susan L. McGovern | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Susan L McGovern | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02698254 |
| Other Study ID Numbers: |
2015-0586 NCI-2016-00536 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2015-0586 ( Other Identifier: M D Anderson Cancer Center ) |
| First Posted: | March 3, 2016 Key Record Dates |
| Last Update Posted: | January 7, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Bevacizumab Antineoplastic Agents, Immunological Endothelial Growth Factors |
Antibodies Immunoglobulins Antibodies, Monoclonal Immunoglobulin G Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Immunologic Factors |