Actively Recruiting
A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with 1p/19q-codeleted low-grade oligodendrogliomas who have been treated with radiotherapy plus PCV chemotherapy. The study aims to evaluate whether delaying radiotherapy until tumor progression can reduce the risk of neurocognitive decline without affecting overall survival. This is a phase 3 randomized trial sponsored by Hospices Civils de Lyon, focusing on preserving brain function while managing tumor growth. Participants are randomly assigned to one of two treatment groups: one group receives six cycles of PCV chemotherapy alone, and the other group receives radiotherapy followed by six cycles of PCV chemotherapy. Radiotherapy delivers 50.4 Gy in 28 sessions using IMRT technique. PCV chemotherapy includes a cycle with CCNU orally on day 1, vincristine intravenously on days 8 and 29, and procarbazine orally from days 8 to 21. Treatment cycles are repeated six times. During the study, participants will undergo neurocognitive examinations and quality of life assessments. Researchers will monitor survival without neurocognitive deterioration over nine years, along with progression-free survival and overall survival. Laboratory tests and physical evaluations will be conducted before and during the study. The trial includes detailed follow-up to assess the long-term effects of the treatments on cognition and tumor control.
CONDITIONS
Brief 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 according to 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 for low-grade oligodendroglioma who have not received radiotherapy or chemotherapy
- Patients eligible after initial follow-up if no anaplastic transformation is seen on MRI
- Patients requiring oncological treatment other than surgery due to progressive disease, symptomatic disease, or specific age and surgical history criteria
- Willing and able to complete neurocognitive examination and quality of life assessments
- Karnofsky performance status of 60 or higher
- Laboratory values meeting specified blood count and liver function criteria
- 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 not willing to use contraception for up to 6 months after PCV treatment
- Prior radiation therapy or chemotherapy for any central nervous system tumor
- Severe co-morbid systemic illnesses or other diseases interfering with safety assessment
- Serious immunocompromised status unrelated to steroids
- Uncontrolled illness or psychiatric/social conditions limiting study compliance
- Use of other investigational agents for the primary tumor (except specific IDH inhibitors)
- Other active malignancy within 5 years except non-melanotic skin cancer or cervical carcinoma in situ
- Contraindications to CCNU, procarbazine, or vincristine including allergies and severe organ failures
- Not covered by the French health insurance system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 6 cycles of PCV chemotherapy and radiotherapy as applicable
Participants receive either 6 cycles of PCV chemotherapy alone or radiotherapy followed by 6 cycles of PCV chemotherapy.
Multiple visits for chemotherapy and radiotherapy sessions as scheduled by the study
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
C
Cécile TROUBA
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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