Proton vs. Photon Radiotherapy for Patients With WHO Grade 2-3 Glioma (NCT07750457) | Clinical Trial Compass
RecruitingNot Applicable
Proton vs. Photon Radiotherapy for Patients With WHO Grade 2-3 Glioma
Germany80 participantsStarted 2019-01-15
Plain-language summary
Patients with grade 2 and 3 gliomas who received photon radiation therapy as part of their standard treatment are at risk of developing cognitive impairments, depending on the tumor's location and the size of the target volume. The extent to which these are caused in individual cases by the brain tissue within the target volume, which is necessarily exposed to a high dose, or whether they can be modified by differences in the exposure of surrounding brain regions exposed to low or moderate doses, is unknown. With the help of proton therapy, the risk of neurocognitive dysfunction could potentially be reduced by decreasing the brain volumes outside the target volume that are exposed to radiation therapy and receive a low dose. Based on current knowledge of relative biological effectiveness, the efficacy of proton therapy on the tumor compared to photon therapy can be considered equivalent with lower levels of uncertainty. In the present study, the impact of photon irradiation versus proton irradiation on neurocognition will now be directly compared. A bicentric, randomized study will investigate whether treating patients with WHO Grade 2 and 3 gliomas with proton radiation results in a different temporal course of neurocognitive function after treatment compared to photon radiation therapy.
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:
* 1\. Histologically confirmed IDH-mutated WHO Grade 2 or 3 glioma with an indication for radiation therapy as determined by the local tumorboard at the study center
* 2\. Tumor classification according to the 2021 WHO Classification, including the presence of the following markers:
* IDH1/2 mutation
* ATRX and/or 1p19q codeletion status
* CDKN2A/B codeletion status
* 3\. A Karnofsky Performance Status of ≥ 70%
* 4\. Patients must be ≥ 18 years of age
* 5\. Radiation therapy must begin within 7 weeks of surgery in patients with CNS WHO Grade 2 IDH-mutated gliomas. In individual cases, the start may be delayed, but not later than 10 weeks after surgery
* 6\. For patients with WHO Grade 2 IDH-mutated CNS gliomas, the following applies:
* There is an indication for radiation therapy (partial tumor resection, age \> 40 years, relevant neurological deficit)
* Enrollment in the study at the time of tumor progression is possible, even without a time constraint relative to the initial surgery, if the following criteria are met:
* There was initially no indication for radiation therapy
* At the time of tumor progression, there is an indication for radiation therapy as determined by the local tumor board
* At the time of recurrence, no repeat surgery is required to confirm the diagnosis if there is no imaging evidence of malignancy (see exclusion criterion No. 4)
* Radiation therapy must begin within 7 weeks after the recurrence MRI (or surgery, if a re…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Neurocognition
Timeframe: three years after finishing radiotherapy