Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial
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ClinicalTrials.gov Identifier: NCT03075072 |
Recruitment Status :
Recruiting
First Posted : March 9, 2017
Last Update Posted : September 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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Brain Metastases | Radiation: Whole brain radiation Radiation: Stereotactic radiation (SRS) | Not Applicable |
This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.
In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 196 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial |
Actual Study Start Date : | April 10, 2017 |
Estimated Primary Completion Date : | September 30, 2024 |
Estimated Study Completion Date : | September 30, 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Whole Brain Radiation
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Radiation: Whole brain radiation
Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation. |
Experimental: Stereotactic Radiation (SRS)
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Radiation: Stereotactic radiation (SRS)
Focused radiation to each individual brain metastasis without treatment of the remainder of the brain. |
- Quality of Life Survey (symptoms and interference) [ Time Frame: 6 months ]Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
- Overall survival [ Time Frame: Through study completion, an average of 1 year ]Clinical Parameter
- Neurologic survival [ Time Frame: Through study completion, an average of 1 year ]Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)
- Incidence and time to detection of new brain metastases [ Time Frame: Through study completion, an average of 1 year ]Radiographic assessment of first appearance of new brain metastases
- Incidence and time to local recurrence of treated brain tumor(s) [ Time Frame: Through study completion, an average of 1 year ]Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation
- Incidence and time to development of radiation necrosis [ Time Frame: Through study completion, an average of 1 year ]Radiographic assessment of first appearance of radiation necrosis
- Incidence and time to development of leptomeningeal disease [ Time Frame: Through study completion, an average of 1 year ]Radiographic assessment of first appearance of leptomeningeal disease
- Incidence and time to salvage craniotomy [ Time Frame: Through study completion, an average of 1 year ]Clinical assessment of first use of neurosurgical resection as salvage therapy
- Incidence and time to additional radiotherapeutic treatments [ Time Frame: Through study completion, an average of 1 year ]Clinical assessment of first use of salvage brain-directed radiation
- Incidence and time to the development of seizures [ Time Frame: Through study completion, an average of 1 year ]Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review
- Incidence and time to neurocognitive decline [ Time Frame: 1 year ]Scale
- Performance status [ Time Frame: Through study completion, an average of 1 year ]Questionnaire - Karnofsky performance status
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible
- Five-twenty intracranial lesions must be present on MRI of the brain
- Age 18-80 years at diagnosis of brain metastases
- Karnofsky performance status of at least 70
Exclusion Criteria:
- Participants who have undergone prior radiation for brain metastases.
- Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study
- Participants who cannot undergo a brain MRI
- Participants who cannot receive gadolinium (MRI contrast)
- Participants with stage IV-V chronic kidney disease or end stage renal disease
- Participants with widespread, definitive leptomeningeal disease
- Participants with small cell lung cancer, lymphoma, or myeloma
- Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
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): NCT03075072
Contact: Ayal Aizer, MD | 617-732-7560 | aaaizer@partners.org | |
Contact: Ivy Ricca, BA | 6175828927 | iricca@mgb.org |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Ayal Aizer, MD MHS 617-732-7560 aaaizer@partners.org | |
Principal Investigator: Ayal Aizer, MD MHS | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02116 | |
Contact: Ayal Aizer, MD 617-732-7560 aaaizer@partners.org |
Principal Investigator: | Ayal Aizer, MD MHS | Brigham and Women's Hospital |
Responsible Party: | Ayal Aizer, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT03075072 |
Other Study ID Numbers: |
16-305 |
First Posted: | March 9, 2017 Key Record Dates |
Last Update Posted: | September 25, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Brain metastases Brain metastasis Lung cancer Melanoma Breast cancer Kidney cancer Renal cell carcinoma Stereotactic radiation Stereotactic radiosurgery SRS Stereotactic Whole brain radiation WBRT |
Hippocampal avoidance Hippocampal sparing Hippocampal Hippocampus Radiation Quality of Life Neurocognitive Neurocognition Survival Salvage MDASI Chemotherapy Recurrence |
Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |