Comparing Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic … (NCT04588246) | Clinical Trial Compass
TerminatedPhase 3
Comparing Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in Patients With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery
Stopped: Inadequate accrual rate
United States, Canada, Hong Kong19 participantsStarted 2021-08-05
Plain-language summary
This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory. The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on neurocognitive function (including thinking and memory). Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine may be effective in reducing the size of the cancer or keeping the cancer the same size when it has spread to the brain and/or come back in other areas of the brain compared to stereotactic radiosurgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have developed their distant brain relapse(s) at least 8 weeks after last SRS and within 21 days prior to randomization
* Distant brain relapse lesions to be treated must measure =\< 3.0 cm in maximal extent and total volume of distant brain relapses to be treated must measure \< 30 mL on the contrast-enhanced diagnostic MRI brain scan obtained within 21 days prior to randomization
* "last SRS" refers to the most recent SRS procedure that the patient received prior to enrollment on this study
* Distant brain relapse lesions must be diagnosed on MRI, which will include the following elements:
* REQUIRED MRI ELEMENTS
* Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization-prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (brain volume imaging) or 3D fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm
* Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged)
* A minimum of one axial T2 fluid attenuated inversion recovery (FLAIR) (preferred) or T2 sequence is required. This can be acquired as a 2D or 3D image. If 2D, the images should be obtained in the axial plane
* ADDITIONAL RECOMMENDATIONS
* Recommendation is that an axial T2 FLAIR (preferred) sequence be performed …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether its findings are reliable enough to guide my treatment decisions?
2The trial was comparing hippocampus-avoiding whole brain radiation to stereotactic radiosurgery for brain metastases that came back after an earlier round of stereotactic radiosurgery — given my specific situation, which of those two approaches would you lean toward for me, and why?
3The primary outcome being measured was neurologic death — what does that tell us about the seriousness of the situation when brain metastases recur after stereotactic radiosurgery, and what are the realistic goals of treatment at that stage?
4Since this trial is no longer enrolling, is there another active clinical trial studying repeat or salvage radiation options for recurrent brain metastases that might be worth exploring for my cancer type?
5Given that my cancer has already spread to the brain and come back after stereotactic radiosurgery, how do you weigh the potential cognitive side effects of whole brain radiation against the risks of trying another round of focused radiosurgery for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Neurologic Death
Timeframe: From baseline to neurologic death or last follow-up. Maximum follow-up at time of study termination was 29.7 months.