Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients Wit… (NCT03180502) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
United States120 participantsStarted 2018-01-23
Plain-language summary
This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.
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:
* PRIOR TO STEP 1 REGISTRATION
* Tumor tissue must be available for submission for central pathology review
* Grade II and III gliomas IDH mutant gliomas including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
* Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in clinical laboratory improvement amendments (CLIA)-approved laboratories and be uploaded prior to Step 2 registration
* Age \>= 18
* The trial is open to both genders
* Only English or French speaking patients are eligible to participate as the cognitive assessments are only available in these languages
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
* History and physical exam, and Karnofsky performance status of \>= 70 within 30 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 60 days prior to registration)
* Platelets \>= 100,000 cells/mm\^3 (within 60 days prior to registration)
* Hemoglobin \>= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable) (within 60 days prior to registration)
* Bilirubin =\< 1.5 upper limit of normal (ULN) (within 60 days prior to registration)
* Alanine aminotransferase (ALT) and aspartate ami…
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 is comparing proton beam radiation to intensity-modulated radiation therapy specifically to see which one better protects brain function — given that my tumor is an IDH mutant grade II or III glioma, do you think preserving cognition is a realistic concern with my treatment plan, and is one of these radiation approaches something worth discussing for me?
2The trial is no longer enrolling new patients, but the research is still ongoing — are there ways my care team could access or apply what's already been learned from this study when deciding between proton beam and IMRT for my situation?
3Since this is a Phase 2 trial focused on measuring changes in cognitive scores rather than survival outcomes, what does that tell us about how much is still unknown regarding long-term benefit, and how does that compare to what we already know about standard radiation approaches for my type of glioma?
4The study specifically targets IDH mutant gliomas — can you explain what my IDH mutation status means for my diagnosis and how it might affect which radiation technique would be most appropriate for me?
5Cognitive testing is the main thing being measured in this trial, but I'm also wondering about day-to-day logistics — if proton beam therapy were something you recommended for me outside of this trial, how would the treatment schedule and availability compare to IMRT, and is that even a practical option where we are?
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
Change in cognition as measured by the Clinical Trial Battery Composite (CTB COMP) score