gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

NCT02444000 | Completed Phase 3 DMC

• 1 other identifier: P130917
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 33

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.

Conditions

Anaplastic Gliomas With 1p/19q Codeletion

Keywords

chemotherapy; PCV; radiotherapy; post operative treatment; anaplastic gliomas; 1p/19q codeletion; cognition

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• progression free survival

  9 years

• overall survival

  9 years

Study Arms (2)

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

Drug: PCV chemotherapy alone

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

Drug: Radiotherapy+PCV chemotherapy

Interventions

Radiotherapy+PCV chemotherapy DRUG

Radiotherapy followed by 6 cycles of PCV

control

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

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of anaplastic glioma by central pathological review
• Tumor is co-deleted for 1p and 19q
• Age ≥ 18 years of age
• Newly diagnosed and ≤3 months from surgical diagnosis
• Willing and able to complete neurocognitive examination and the QOL
• Karnofsky performance status ≥ 60
• The following laboratory values obtained ≤ 21 days prior to registration:
• Absolute neutrophil count (ANC) ≥1500 /mm3
• Platelet count ≥100,000 / mm3
• Hemoglobin \> 9.0 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• SGOT (AST) ≤ 3 x ULN
• Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
• Provide informed written consent

You may not qualify if:

• Pregnant and nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of PCV.
• Received any prior radiation therapy or chemotherapy for any CNS neoplasm.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Association de Neuro-Oncologues d'Expression Francaise: collaborator

Study Sites (33)

CHU d'Amiens- CHU nord

Amiens, 80000, France

Location

CHU D'Anger

Angers, 49000, France

Location

CHU annecy genevois

Annecy, 74000, France

Location

CHU de Bordaux

Bordeaux, 33000, France

Location

Hopital de la Cavale Blanche

Brest, 29000, France

Location

CHU de Caen

Caen, 30000, France

Location

Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

CH Louis Pasteur

Colmar, 68000, France

Location

Hopital François Mitterand

Dijon, 21000, France

Location

CHU Sud Réunion

La Réunion, 97000, France

Location

Hopital Roger Salengro

Lille, 59000, France

Location

Chu Dupuytren

Limoges, 87000, France

Location

Centre Hospitalier de Bretagne Sud - Hôpital du Scorff

Lorient, 56000, France

Location

GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

Lyon, 69000, France

Location

Hôpital Pierre Wertheimer

Lyon, 69000, France

Location

CHU la Timone

Marseille, 13000, France

Location

Hopital CLAIRVAL

Marseille, 13000, France

Location

ICM, Institut régional du Cancer de Montpellier

Montpellier, 34000, France

Location

Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau

Nantes, 44000, France

Location

Hopital PASTEUR

Nice, 06000, France

Location

HIA du Val de Grâce

Paris, 75005, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Groupe Hospitalier Pitié Salpetriere

Paris, 75013, France

Location

Centre Hospitalier Perpignan

Perpignan, 49000, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CLCC Eugène Marquis

Rennes, 44000, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Hôpital Nord, CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Institut Pul STRAUSS

Strasbourg, 67000, France

Location

Hôpital Foch

Suresnes, 92000, France

Location

IUCT Oncopole - CLCC Institut Claudius Regaud

Toulouse, 31000, France

Location

CHU Bretonneau

Tours, 37000, France

Location

CLCC Institut Gustave Roussy

Villejuif, 94800, France

Location

Study Officials

• Caroline DEHAIS, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: September 22, 2015
• Primary Completion: October 11, 2022
• Study Completion: September 21, 2024
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (33)