Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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