Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04702581

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

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

280

Participants Needed

26

Research Sites

468 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Tumor is co-deleted for 1p and 19q and IDH-mutant (IDH1 or IDH2) based on 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 or re-surgery for low-grade oligodendroglioma without prior radiotherapy or chemotherapy
  • No evidence of anaplastic transformation on MRI after surgery or re-surgery
  • Require oncological treatment other than surgery due to progressive or symptomatic disease, or based on age and surgical history criteria
  • Willing and able to complete neurocognitive and quality of life assessments
  • Karnofsky performance status of 60 or higher
  • Laboratory values within specified limits including ANC ≥1500/mm3, platelet count ≥100,000/mm3, hemoglobin >9.0 g/dL, total bilirubin ≤1.5 x ULN, SGOT (AST) ≤3 x ULN
  • Negative pregnancy test within 7 days before registration for women of childbearing potential
  • Provide informed written consent
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • Men or women of childbearing potential unwilling to use adequate contraception for 6 months after PCV completion
  • Prior radiation therapy or chemotherapy for any central nervous system neoplasm
  • Serious co-morbid systemic illnesses or other severe diseases interfering with safety assessment
  • Serious immunocompromised status unrelated to steroids
  • Uncontrolled intercurrent illness or psychiatric/social conditions limiting study compliance
  • Receiving other investigational agents for the primary tumor except specific IDH inhibitors
  • Active malignancy within 5 years except non-melanotic skin cancer or carcinoma in situ of the cervix
  • Contraindications to CCNU, procarbazine, or vincristine including hypersensitivity or severe organ failure
  • Not dependent on the French health insurance system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

CHU d'Amiens-Picardie Site Sud

Amiens, France, 80054

Actively Recruiting

2

Institut de Cancerologie de l'Ouest

Angers, France, 49055

Actively Recruiting

3

CHU de Bordeaux Hôpital Saint André

Bordeaux, France, 33075

Actively Recruiting

4

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

Brest, France, 29200

Actively Recruiting

5

Hospices Civils de Lyon

Bron, France, 69500

Actively Recruiting

6

CHU de Caen

Caen, France, 14033

Not Yet Recruiting

7

Hôpital d'Instruction des Armées PERCY

Clamart, France, 92141

Not Yet Recruiting

8

Hôpital Pasteur - Hôpitaux civils de Colmar

Colmar, France, 68024

Not Yet Recruiting

9

Centre Georges Francois Leclerc

Dijon, France, 21000

Not Yet Recruiting

10

Hôpital Roger Salengro CHU de Lille

Lille, France, 59037

Actively Recruiting

11

CHU de Limoges

Limoges, France, 87042

Not Yet Recruiting

12

Centre Léon Bérard

Lyon, France, 69008

Not Yet Recruiting

13

Hôpital Timone

Marseille, France, 13005

Actively Recruiting

14

CHU de Nice Hôpital Pasteur

Nice, France, 06000

Not Yet Recruiting

15

Hôpital Saint-Louis, AP-HP

Paris, France, 75010

Actively Recruiting

16

GH Pitié Salpêtrière

Paris, France, 75651

Actively Recruiting

17

CH Annecy Genevois site Annecy

Pringy, France, 74374

Not Yet Recruiting

18

Centre Eugène Marquis

Rennes, France, 35042

Actively Recruiting

19

Centre Henri Becquerel

Rouen, France, 76038

Actively Recruiting

20

CHU Saint-Etienne

Saint-Etienne, France, 42055

Not Yet Recruiting

21

Institut de Cancerologie de l'Ouest

Saint-Herblain, France, 44805

Actively Recruiting

22

Centre de Lutte Contre le Cancer PAUL STRAUSS

Strasbourg, France, 67200

Actively Recruiting

23

Hôpital Foch

Suresnes, France, 92150

Not Yet Recruiting

24

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France, 31059

Not Yet Recruiting

25

CHRU de Tours

Tours, France, 37044

Not Yet Recruiting

26

Gustave Roussy

Villejuif, France, 94805

Not Yet Recruiting

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Research Team

F

François DUCRAY, MD, PhD

CONTACT

C

Cécile TROUBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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