A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery
Condition(s) studied
Investigational drug(s) / intervention(s)
PCV chemotherapy: 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 and PCV chemotherapy: 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
Study summary
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.
Eligibility
Primary outcome measure(s)
- Survival without neurocognitive deterioration — During 9 years
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.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU d'Amiens-Picardie Site Sud | Amiens | France | Recruiting |
| Institut de Cancerologie de l'Ouest | Angers | France | Recruiting |
| CHU de Bordeaux Hôpital Saint André | Bordeaux | France | Recruiting |
| Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan | Brest | France | Recruiting |
| Hospices Civils de Lyon | Bron | France | Recruiting |
| CHU de Caen | Caen | France | Not Yet Recruiting |
| Hôpital d'Instruction des Armées PERCY | Clamart | France | Not Yet Recruiting |
| Hôpital Pasteur - Hôpitaux civils de Colmar | Colmar | France | Not Yet Recruiting |
| Centre Georges Francois Leclerc | Dijon | France | Not Yet Recruiting |
| Hôpital Roger Salengro CHU de Lille | Lille | France | Recruiting |
| CHU de Limoges | Limoges | France | Not Yet Recruiting |
| Centre Léon Bérard | Lyon | France | Not Yet Recruiting |
| Hôpital Timone | Marseille | France | Recruiting |
| CHU de Nice Hôpital Pasteur | Nice | France | Not Yet Recruiting |
| Hôpital Saint-Louis, AP-HP | Paris | France | Recruiting |
| GH Pitié Salpêtrière | Paris | France | Recruiting |
| CH Annecy Genevois site Annecy | Pringy | France | Not Yet Recruiting |
| Centre Eugène Marquis | Rennes | France | Recruiting |
| Centre Henri Becquerel | Rouen | France | Recruiting |
| CHU Saint-Etienne | Saint-Etienne | France | Not Yet Recruiting |
| Institut de Cancerologie de l'Ouest | Saint-Herblain | France | Recruiting |
| Centre de Lutte Contre le Cancer PAUL STRAUSS | Strasbourg | France | Recruiting |
| Hôpital Foch | Suresnes | France | Not Yet Recruiting |
| Institut Universitaire du Cancer Toulouse Oncopole | Toulouse | France | Not Yet Recruiting |
| CHRU de Tours | Tours | France | Not Yet Recruiting |
| Gustave Roussy | Villejuif | France | Not Yet Recruiting |
More Hospices Civils de Lyon trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04702581 on ClinicalTrials.gov ↗ ← All trials in France