What is PCV chemotherapy studying for low-grade oligodendroglioma?

PCV chemotherapy is being studied to see if delaying radiotherapy can reduce brain function decline without affecting survival in patients with low-grade oligodendroglioma. The trial compares PCV alone to radiotherapy followed by PCV, aiming to find the best approach to treatment while preserving cognitive abilities. Hospices Civils de Lyon sponsors this important research.

Who may be eligible for this low-grade oligodendroglioma clinical trial?

Adults aged 18 years and older with a diagnosis of 1p/19q-codeleted, IDH-mutant low-grade oligodendroglioma may be eligible. Participants should not have had prior radiotherapy or chemotherapy for this tumor, be able to complete cognitive tests, and have a Karnofsky performance status of 60 or more. Please review eligibility criteria for more details.

Is there any cost to participate in this low-grade oligodendroglioma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID04702581

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

Led by Hospices Civils de Lyon · Updated on 2026-01-29

280

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Tumor is co-deleted for 1p and 19q and IDH-mutant according to local diagnosis
Histological confirmation of low-grade oligodendroglioma by central pathological review according to WHO 2016 classification
Age 18 years or older
Patients with prior surgery for low-grade oligodendroglioma who have not received radiotherapy or chemotherapy
Patients eligible after initial follow-up if no anaplastic transformation is seen on MRI
Patients requiring oncological treatment other than surgery due to progressive disease, symptomatic disease, or specific age and surgical history criteria
Willing and able to complete neurocognitive examination and quality of life assessments
Karnofsky performance status of 60 or higher
Laboratory values meeting specified blood count and liver function criteria
Negative pregnancy test within 7 days before registration for women of childbearing potential
Provide informed written consent

You will not qualify if you...

Pregnant or nursing women
Men or women of childbearing potential not willing to use contraception for up to 6 months after PCV treatment
Prior radiation therapy or chemotherapy for any central nervous system tumor
Severe co-morbid systemic illnesses or other diseases interfering with safety assessment
Serious immunocompromised status unrelated to steroids
Uncontrolled illness or psychiatric/social conditions limiting study compliance
Use of other investigational agents for the primary tumor (except specific IDH inhibitors)
Other active malignancy within 5 years except non-melanotic skin cancer or cervical carcinoma in situ
Contraindications to CCNU, procarbazine, or vincristine including allergies and severe organ failures
Not covered by the French health insurance system

Research Team

François DUCRAY, MD, PhD

Cécile TROUBA

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