Evaluation of the efficacy of the combination of standard systemic treatment plus SRS compared to standard systemic treatment alone in patients with brain metastases of melanoma or NSCLC.
Aim of the study
In this clinical trial, we want to find out when is the best time to administer radiotherapy to the brain to slow down the growth of your brain metastases. We also want to find out how radiotherapy affects mental functions (e.g. attention, memory and speech), activities of daily living (e.g. dressing, personal hygiene) and quality of life.
Who can take part?
Patients with newly diagnosed and untreated (except for surgery) asymptomatic or oligosymptomatic brain metastases of melanoma or NSCLC
Procedure
For melanoma patients: In this study you will receive immunotherapy to treat your melanoma. Immunotherapy is the usual treatment for skin cancer. Your investigator will decide what type of immunotherapy you will receive and how it will be administered. In this study, about half of the patients receive radiotherapy of the brain at about the same time as the start of immunotherapy. The other half of the patients can receive radiotherapy of the brain at a later date if their brain metastases progress. A computer program will decide at random whether or not you will receive radiotherapy at the start of this study. If you receive radiotherapy, your investigator and the local radiotherapy team will decide how and in what form it will be administered for NSCLC patients: In this study, you will receive the usual drug therapy for your lung cancer. Your investigator will decide which drug therapy is best for you and how it should be administered. About half of the patients receive radiotherapy of the brain at about the same time as the start of drug therapy for their lung cancer. The other half of the patients can receive radiotherapy of the brain at a later date if their brain metastases progress. A computer program will decide at random whether or not you will receive radiotherapy at the start of this study. If you receive radiotherapy, your investigator and the local radiotherapy team will decide how and in what form it will be administered.
Compensation
None
Original study name
A multicenter, randomized, open-label, phase III trial of stereotactic radiosurgery in addition to standard systemic therapy in patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligosymptomatic brain metastases
BASEC number
2022-01064
Financial support from
European Thoracic Oncology Platform (ETOP)