A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
Because of their prolonged survival, patients with 1p/19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival.
Eligibility criteria
Qualifiers
Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to local diagnosis
Histological confirmation of low-grade oligodendroglioma by central pathological review according to WHO 2016 classification
Age ≥ 18 years
Patients with one or several prior surgical procedure for a low-grade oligodendroglioma and who undergo a resurgery are eligible if they have not received prior radiotheray or chemotherapy and if the last histological diagnosis is a low-grade oligodendroglioma prior use of specific HDI prohibitions is permitted
Disqualifiers
Pregnant and nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception for up to 6 months following the completion of PCV.
Received any prior radiation therapy or chemotherapy for any CNS neoplasm.
Co-morbid systemic illnesses or other severe concurrent disease which would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Trial design
Treatments tested in this trial
- PCV chemotherapy
- Radiotherapy and PCV chemotherapy
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov