Proton Radiation Therapy for Gliomas (NCT01358058) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Proton Radiation Therapy for Gliomas
United States63 participantsStarted 2011-05
Plain-language summary
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.
In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.
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:
* Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
* Subject must be indicated for radiation therapy
* Life expectancy greater than 5 years
* Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
* Able to speak and comprehend English
* Recovered from adverse events due to agents administered more than 4 weeks before entering study
* Able to undergo MRI scans
Exclusion Criteria:
* Prior cranial radiation therapy
* Chemotherapy within 4 weeks prior to entering study
* Pregnant or breastfeeding
* Known brain metastases
* Baseline neurocognitive or emotional disorders
* Uncontrolled intercurrent illness
* History of a different malignancy unless disease-free for at least 5 years
* HIV positive on antiretroviral therapy
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 studying proton radiation therapy for low-grade and certain grade 3 gliomas — how does proton therapy differ from standard photon radiation in terms of where the radiation goes in my brain, and could that difference matter for my specific tumor?
2Since this trial is listed as 'active, not recruiting,' what does that mean for my options — is it worth asking the research team if there's any possibility of joining, or should we focus on finding comparable proton therapy outside of a trial?
3My tumor's characteristics — like whether it has an IDH1 mutation or a 1p/19q codeletion — seem to affect eligibility here; do my pathology results match the profile this study is targeting, and how do those genetic markers affect my overall treatment plan?
4The trial's phase is listed as 'NA,' which means there may be less of a formal structure around dose-escalation or safety testing — what do we actually know so far about the safety and efficacy of proton therapy for gliomas like mine based on what's been observed in this or similar studies?
5Before considering a specialized radiation approach like this, should I first discuss whether chemotherapy, standard radiation, or a watch-and-wait approach might be more appropriate for where my tumor is and how it's behaving right now?
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.