RecruitingPhase 3NCT04702581

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


Sponsor

Hospices Civils de Lyon

Enrollment

280 participants

Start Date

Dec 7, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PCV chemotherapy and a drug called Radiotherapy and PCV chemotherapy for people with 1p19q codeletion, low-grade oligodendroglioma, and other related conditions. The study is currently recruiting participants at 26 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPCV 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.

DRUGRadiotherapy 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

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NCT04702581


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