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RECRUITING
NCT04702581
PHASE3

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2021-12-07

Completion Date

2030-12

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DRUG

PCV chemotherapy

1. cycle of PCV chemotherapy is given as: * Day 1: CCNU 110 mg/m2 orally; * Days 8 and 29: Vincristine 1.4 mg/m2 IV; * Days 8 to 21: Procarbazine 60 mg/m2 orally 6 cycles are given.

DRUG

Radiotherapy and PCV chemotherapy

Radiotherapy will deliver 50.4 Gy in 28 fractions of 1.8 Gy using IMRT technique. Followed by 6 cycles of PCV chemotherapy 1 cycle of PCV is given as: * Day 1: CCNU 110 mg/m2 orally; * Days 8 and 29: Vincristine 1.4 mg/m2 IV; * Days 8 to 21: Procarbazine 60 mg/m2 orally

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

CHU de Limoges

Limoges, France

Centre Léon Bérard

Lyon, France

Hôpital Timone

Marseille, France

CHU de Nice Hôpital Pasteur

Nice, France

Hôpital Saint-Louis, AP-HP

Paris, France

GH Pitié Salpêtrière

Paris, France

CH Annecy Genevois site Annecy

Pringy, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

CHU Saint-Etienne

Saint-Etienne, France

Institut de Cancerologie de l'Ouest

Saint-Herblain, France

Centre de Lutte Contre le Cancer PAUL STRAUSS

Strasbourg, France

Hôpital Foch

Suresnes, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

CHRU de Tours

Tours, France

Gustave Roussy

Villejuif, France