gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

Phase 3

Active, not recruiting

• Conditions: Anaplastic Gliomas With 1p/19q Codeletion
• Interventions: Drug: PCV chemotherapy alone; 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.

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-14
• Study Start: 2015-09-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26
• Primary Completion: 2024-09-21
• Study Completion: 2024-09-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

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

CHU D'Anger; 🇫🇷 Angers, France

CHU annecy genevois; 🇫🇷 Annecy, France

CHU de Bordaux; 🇫🇷 Bordeaux, France

Hopital de la Cavale Blanche; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

Hopital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

CH Louis Pasteur; 🇫🇷 Colmar, France

Hopital François Mitterand; 🇫🇷 Dijon, France

CHU Sud Réunion; 🇫🇷 La Réunion, France

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