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| Name | Class |
|---|---|
| Association de Neuro-Oncologues d'Expression Francaise | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV chemotherapy alone | Drug | PCV cycles are 6 weeks long 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | 9 years | |
| overall survival | 9 years |
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Inclusion criteria :
Histological confirmation of anaplastic glioma by central pathological review
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Caroline DEHAIS, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens- CHU nord | Amiens | 80000 | France | |||
| CHU D'Anger |
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| Radiotherapy+PCV chemotherapy | Drug | Radiotherapy followed by 6 cycles of PCV |
|
| Angers |
| 49000 |
| France |
| CHU annecy genevois | Annecy | 74000 | France |
| CHU de Bordaux | Bordeaux | 33000 | France |
| Hopital de la Cavale Blanche | Brest | 29000 | France |
| CHU de Caen | Caen | 30000 | France |
| Hopital Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| CH Louis Pasteur | Colmar | 68000 | France |
| Hopital François Mitterand | Dijon | 21000 | France |
| CHU Sud Réunion | La Réunion | 97000 | France |
| Hopital Roger Salengro | Lille | 59000 | France |
| Chu Dupuytren | Limoges | 87000 | France |
| Centre Hospitalier de Bretagne Sud - Hôpital du Scorff | Lorient | 56000 | France |
| GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP | Lyon | 69000 | France |
| Hôpital Pierre Wertheimer | Lyon | 69000 | France |
| CHU la Timone | Marseille | 13000 | France |
| Hopital CLAIRVAL | Marseille | 13000 | France |
| ICM, Institut régional du Cancer de Montpellier | Montpellier | 34000 | France |
| Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau | Nantes | 44000 | France |
| Hopital PASTEUR | Nice | 06000 | France |
| HIA du Val de Grâce | Paris | 75005 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Groupe Hospitalier Pitié Salpetriere | Paris | 75013 | France |
| Centre Hospitalier Perpignan | Perpignan | 49000 | France |
| CHU de Poitiers | Poitiers | 86000 | France |
| CLCC Eugène Marquis | Rennes | 44000 | France |
| CHU de Rouen | Rouen | 76000 | France |
| Hôpital Nord, CHU de Saint-Etienne | Saint-Etienne | 42000 | France |
| Institut Pul STRAUSS | Strasbourg | 67000 | France |
| Hôpital Foch | Suresnes | 92000 | France |
| IUCT Oncopole - CLCC Institut Claudius Regaud | Toulouse | 31000 | France |
| CHU Bretonneau | Tours | 37000 | France |
| CLCC Institut Gustave Roussy | Villejuif | 94800 | France |