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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
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.
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
CHU d'Amiens-Picardie Site Sud
Amiens, France
RECRUITINGInstitut de Cancerologie de l'Ouest
Angers, France
RECRUITINGCHU de Bordeaux Hôpital Saint André
Bordeaux, France
RECRUITINGInstitut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan
Brest, France
RECRUITINGHospices Civils de Lyon
Bron, France
RECRUITINGCHU de Caen
Caen, France
NOT_YET_RECRUITINGHôpital d'Instruction des Armées PERCY
Clamart, France
NOT_YET_RECRUITINGHôpital Pasteur - Hôpitaux civils de Colmar
Colmar, France
NOT_YET_RECRUITINGCentre Georges Francois Leclerc
Dijon, France
NOT_YET_RECRUITINGHôpital Roger Salengro CHU de Lille
Lille, France
RECRUITING...and 16 more locations
Survival without neurocognitive deterioration
Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study randomization 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.
Time frame: During 9 years
Progression free survival
Time from study randomization to the time of progression of the tumor
Time frame: During 9 years
Overall survival
Time from study randomization to the time of death
Time frame: During 9 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.