Loading clinical trials...

A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery

NCT04702581•Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 requiring an oncological treatment other than surgery because of one or more of the following characteristics:
•* Progressive disease defined as documented growth prior to inclusion
•* Symptomatic disease defined as the presence of neurological or cognitive symptoms or refractory seizures defined as having both persistent seizures interfering with everyday life activities other than driving a car and three lines of anti-epileptic drug regimen had not worked, including at least one combination regimen.
•* Age ≥ 40 and any surgical therapy
•* Age \< 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)
•Willing and able to complete neurocognitive examination and the QOL
•Karnofsky performance status ≥ 60
+8 more criteria

Exclusion Criteria

•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.
•Concomitant serious immunocompromised status (other than that related to concomitant steroids).
•Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
•Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm (except specific inhibitors of IDH)
•Other active malignancy within 5 years of registration. Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
•Contra-indication to CCNU: hypersensitivity to CCNU, wheat allergy, association to yellow fever vaccin
•Contra-indication to Procarbazine: severe renal failure, severe hepatic failure, hypersensitivity to procarbazine, association to yellow fever vaccin
+2 more criteria

Locations (26)

CHU d'Amiens-Picardie Site Sud

Amiens, France

Institut de Cancerologie de l'Ouest

Angers, France

CHU de Bordeaux Hôpital Saint André

Bordeaux, France

Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan

Brest, France

Hospices Civils de Lyon

Bron, France

CHU de Caen

Caen, France

Hôpital d'Instruction des Armées PERCY

Clamart, France

Hôpital Pasteur - Hôpitaux civils de Colmar

Colmar, France

Centre Georges Francois Leclerc

Dijon, France

Hôpital Roger Salengro CHU de Lille

Lille, France

Key Dates

Start Date

December 7, 2021

Primary Completion Date

December 1, 2030

Completion Date

December 1, 2030

Last Updated

January 29, 2026

Enrollment

280

ESTIMATED participants

Conditions

OligodendrogliomaLow-grade Oligodendroglioma1p19q Codeletion

Interventions

PCV chemotherapy

DRUG

Radiotherapy and PCV chemotherapy

DRUG

Contacts

François DUCRAY, MD, PhD

CONTACT

+33(0) 4 72 35 78 06 francois.ducray@chu-lyon.fr

Cécile TROUBA

CONTACT

+33(0) 4 72 35 69 15 cecile.trouba@chu-lyon.fr

Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

NCT05956821

Glioblastoma MultiformeAnaplastic Astrocytoma+6 more

View study

RECRUITINGNA

PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas

NCT05190172

OligodendrogliomaOligodendroglioma, Anaplastic+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas

A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.

PARP Inhibition for Gliomas (PI-4G or π4g)

Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma