Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)

Launched by TECHNISCHE UNIVERSITÄT DRESDEN · Jul 2, 2016

Keywords

ClinConnect Summary

This clinical trial, called ProtoChoice-Hirn, is studying the effects of two types of radiation therapy—proton therapy and photon therapy—on patients with brain tumors. The goal is to compare how much each type of treatment causes long-term side effects (toxicity) one year after treatment. Researchers believe that proton therapy may lead to 15% fewer chronic side effects compared to photon therapy.

To participate in this trial, patients must be at least 18 years old and have certain types of brain tumors, including gliomas, meningiomas, or other specific tumors. They should also be in good enough health to handle outpatient treatment. Patients who have already had radiation for their tumors may still be eligible if their situation meets specific criteria. Throughout the trial, participants will receive high-dose radiation therapy, and they will be closely monitored for any side effects to help understand how each treatment works. This study is currently recruiting participants, and it aims to provide valuable information that could improve radiation treatment for brain tumors in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • primary brain tumor: gliomas (low or high grade), intracerebral meningiomas, pituitary adenomas, craniopharyngioma and other rare brain tumors or
• • brain tumor recurrence without pre-irradiation or
• • brain tumor recurrence with pre-irradiation \> 40 Gy in the overlap region with the recurrence region
• • indication for radiotherapy or radiochemotherapy
• • Both proton and photon therapy are possible from a medical point of view (that is no standard indication for protons or standard indication for example one-time stereotaxy
• • age \>= 18 years
• • general condition ECOG ≤ 2, outpatient basis possible
• • indication for high dose (except group 4) radiotherapy or radiochemotherapy
• • capacity to consent and present written informed consent
• Exclusion Criteria:
• • lack of capacity to consent or lack of written consent
• • cerebral lymphomas
• • brain metastases
• • very small tumors (for example acoustic neuromas, very small recurrences) for this is a proton therapy from a medical point of view no alternative to a stereotactic radiotherapy
• • inability to MRI planning (eg. contraindications to performing MRI)
• • lack of compliance of the patient
• • lack of or limited possibility of a reproducible storage (eg by severe restriction of mobility of the patient)
• • missing or limited possibility of regular follow-up visits in accordance with the study protocol