gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas
- Conditions
- Anaplastic Gliomas With 1p/19q Codeletion
- Interventions
- Drug: Radiotherapy+PCV chemotherapy
- Registration Number
- NCT02444000
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.
- Detailed Description
Multicentric, Randomized phase III study (1:1), Population: newly diagnosed 1p/19-codeleted anaplastic gliomas, Primary objective: To determine whether treating newly diagnosed 1p/19q-codeleted anaplastic gliomas with PCV alone can increase overall survival without neurocognitive deterioration Control group: radiotherapy followed by 6 cycles of PCV chemotherapy. Experimental group: 6 cycles of PCV chemotherapy (radiotherapy being deferred at the time of progression).
Number of centres participating: the 33 centers of the POLA network Recruitment duration: 7 years, the accrual rate being 40 patients per year, and patients are followed-up until the end of the trial.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 280
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental PCV chemotherapy alone Administration of 6 cycles of PCV chemotherapy 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 control Radiotherapy+PCV chemotherapy radiotherapy followed by 6 cycles of PCV chemotherapy 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
- Primary Outcome Measures
Name Time Method Survival without neurocognitive deterioration 9 years Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study registration to failure in any of the 6 cognitive domains that will be explored (i.e memory, working memory, language, visuo-spatial ability, cognitive executive functions, behavioral executive functions) or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method progression free survival 9 years overall survival 9 years
Trial Locations
- Locations (33)
CHU d'Amiens- CHU nord
🇫🇷Amiens, France
Hopital PASTEUR
🇫🇷Nice, France
Hopital CLAIRVAL
🇫🇷Marseille, France
CHU D'Anger
🇫🇷Angers, France
CHU de Bordaux
🇫🇷Bordeaux, France
CHU annecy genevois
🇫🇷Annecy, France
Hopital de la Cavale Blanche
🇫🇷Brest, France
CHU de Caen
🇫🇷Caen, France
CH Louis Pasteur
🇫🇷Colmar, France
Hopital François Mitterand
🇫🇷Dijon, France
CHU Sud Réunion
🇫🇷La Réunion, France
Hopital Roger Salengro
🇫🇷Lille, France
Chu Dupuytren
🇫🇷Limoges, France
Centre Hospitalier de Bretagne Sud - Hôpital du Scorff
🇫🇷Lorient, France
GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
🇫🇷Lyon, France
Hôpital Pierre Wertheimer
🇫🇷Lyon, France
CHU la Timone
🇫🇷Marseille, France
ICM, Institut régional du Cancer de Montpellier
🇫🇷Montpellier, France
Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau
🇫🇷Nantes, France
HIA du Val de Grâce
🇫🇷Paris, France
Hopital Saint Louis
🇫🇷Paris, France
Groupe Hospitalier Pitié Salpetriere
🇫🇷Paris, France
Centre Hospitalier Perpignan
🇫🇷Perpignan, France
CHU de Poitiers
🇫🇷Poitiers, France
CLCC Eugène Marquis
🇫🇷Rennes, France
CHU de Rouen
🇫🇷Rouen, France
Hôpital Nord, CHU de Saint-Etienne
🇫🇷Saint-Étienne, France
Institut Pul STRAUSS
🇫🇷Strasbourg, France
Hôpital Foch
🇫🇷Suresnes, France
IUCT Oncopole - CLCC Institut Claudius Regaud
🇫🇷Toulouse, France
CHU Bretonneau
🇫🇷Tours, France
CLCC Institut Gustave Roussy
🇫🇷Villejuif, France
Hopital Gabriel Montpied
🇫🇷Clermont-Ferrand, France