Study Comparing Delayed Radiotherapy Versus Immediate Radiotherapy Plus PCV Chemotherapy in Adults with 1p19q Codeleted Low-grade Oligodendroglioma

What this Trial Is About

Researchers are studying patients with 1p19q-codeleted low-grade oligodendrogliomas who have been treated with radiotherapy plus PCV chemotherapy. The study aims to evaluate whether delaying radiotherapy until tumor progression can reduce the risk of neurocognitive decline without affecting overall survival. This is a phase 3 randomized trial sponsored by Hospices Civils de Lyon, focusing on preserving brain function while managing tumor growth. Participants are randomly assigned to one of two treatment groups one group receives six cycles of PCV chemotherapy alone, and the other group receives radiotherapy followed by six cycles of PCV chemotherapy. Radiotherapy delivers 50.4 Gy in 28 sessions using IMRT technique. PCV chemotherapy includes a cycle with CCNU orally on day 1, vincristine intravenously on days 8 and 29, and procarbazine orally from days 8 to 21. Treatment cycles are repeated six times. During the study, participants will undergo neurocognitive examinations and quality of life assessments. Researchers will monitor survival without neurocognitive deterioration over nine years, along with progression-free survival and overall survival. Laboratory tests and physical evaluations will be conducted before and during the study. The trial includes detailed follow-up to assess the long-term effects of the treatments on cognition and tumor control.

A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery