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Proton Beam vs IMRT for Brain Cancer
Study Summary
This trial is studying proton beam radiation therapy and intensity-modulated radiation therapy to see how well they work in preserving brain function in patients with IDH mutant grade II or III glioma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 35 Patients • NCT02073968Trial Design
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Who is running the clinical trial?
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- My cancer is not located in the lower part of my brain.I am not using memantine during or after radiation treatment.I was hospitalized for heart failure that is moderately severe or worse in the last year.I do not have a severe lung condition that requires hospitalization or would stop me from receiving the study treatment.I am HIV positive with a low CD4 count or have AIDS.I don't have any major illnesses or mental health treatments that would stop me from completing the study treatment.I speak English and can complete assessments in it.I must have a detailed MRI with contrast for my treatment planning.I have severe kidney disease requiring or recommended to have dialysis.I have financial approval for proton therapy before the next treatment phase.My tests confirm I have an IDH mutation and my 1p/19q status is known.My hemoglobin level is at least 10.0 g/dl, possibly after receiving treatment.I have a serious heart rhythm problem that is not well-controlled.I haven't had serious wounds, ulcers, fractures, or major surgeries in the last 28 days, except for a specific brain surgery.I have had chemotherapy or radiotherapy for a brain tumor before.I will only be using temozolomide chemotherapy with my radiation treatment.I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.My diagnosis is either glioblastoma or pilocytic astrocytoma.I am currently on IV antibiotics for a bacterial or fungal infection.I do not have liver problems causing jaundice or blood clotting issues.I have a history of brain or mental health issues affecting my thinking.I can provide a sample of my tumor for review.I can care for myself but may not be able to do active work.I have completed all required quality of life questionnaires.I have had radiation therapy to my head or neck before.I haven't had a severe heart attack or signs of one in the last 6 months.My brain tumor is IDH-mutant and graded II or III.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.
- Group 1: Arm I (photon-based IMRT, temozolomide)
- Group 2: Arm II (proton beam radiation therapy, temozolomide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are numerous hospitals conducting this experiment in North America?
"There are a total of 21 locations where this clinical trial is taking place. Some notable hospitals include University Hospitals Portage Medical Center in Ravenna, Maryland Proton Treatment Center in Baltimore, and Massachusetts General Hospital Cancer Center in Boston."
How many does this research project hope to include?
"In order to properly conduct this study, we require 120 patients that meet a set of specific conditions. Those chosen to participate will visit one of the many sites hosting this trial, such as University Hospitals Portage Medical Center in Ravenna, Ohio or Maryland Proton Treatment Center in Baltimore, Massachusetts."
Is this the first time this research has been conducted?
"Since 2002, Proton Beam Radiation Therapy has been the focus of many academic and medical studies. The first trial was sponsored by Schering-Plough and included 60 patients. Based on the success of that initial study, Proton Beam Radiation Therapy received Phase 2 drug approval. Currently, there are 219 ongoing trials involving this treatment across 947 cities in 38 countries."
Are individuals who suffer from this condition able to enroll in the program at this time?
"That is correct. The clinical trial, which was originally posted on 8/2/2017 and last updated on 8/10/2022, is recruiting patients at 21 different sites. In total, they are looking for 120 individuals to take part in the study."
What are some of the most common reasons why patients might seek out Proton Beam Radiation Therapy?
"Proton Beam Radiation Therapy is often used to treat nitrosourea treatment. However, it has also been found effective in treating advance directives, refractory, advanced mycosis fungoides, and refractory neuroblastoma."
Has Proton Beam Radiation Therapy been cleared by the FDA?
"Proton Beam Radiation Therapy is in Phase 2 of clinical trials, meaning that while there is some evidence supporting its safety, there is currently no data to suggest that the therapy is effective."
Does Proton Beam Radiation Therapy have a long and successful clinical history?
"Proton Beam Radiation Therapy was first studied in the year 2002 at Memorial Sloan Kettering Cancer Center. To date there have been 299 completed trials. There are presently 219 live clinical trials, with a large number of these trials based in Ravenna, Ohio."
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