gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

Last updated: October 24, 2022
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Not Recruiting

Phase

3

Condition

Brain Cancer

Cancer

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT02444000
P130097
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria :

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

Exclusion criteria :

  • 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.

Study Design

Total Participants: 280
Study Start date:
September 22, 2015
Estimated Completion Date:
September 21, 2024

Study 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.

Connect with a study center

  • CHU d'Amiens- CHU nord

    Amiens, 80000
    France

    Site Not Available

  • CHU D'Anger

    Angers, 49000
    France

    Site Not Available

  • CHU annecy genevois

    Annecy, 74000
    France

    Site Not Available

  • CHU de Bordaux

    Bordeaux, 33000
    France

    Site Not Available

  • Hopital de la Cavale Blanche

    Brest, 29000
    France

    Site Not Available

  • CHU de Caen

    Caen, 30000
    France

    Site Not Available

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • CH Louis Pasteur

    Colmar, 68000
    France

    Site Not Available

  • Hopital François Mitterand

    Dijon, 21000
    France

    Site Not Available

  • CHU Sud Réunion

    La Réunion, 97000
    France

    Site Not Available

  • Hopital Roger Salengro

    Lille, 59000
    France

    Site Not Available

  • Chu Dupuytren

    Limoges, 87000
    France

    Site Not Available

  • Centre Hospitalier de Bretagne Sud - Hôpital du Scorff

    Lorient, 56000
    France

    Site Not Available

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

    Lyon, 69000
    France

    Site Not Available

  • Hôpital Pierre Wertheimer

    Lyon, 69000
    France

    Site Not Available

  • CHU la Timone

    Marseille, 13000
    France

    Site Not Available

  • Hopital CLAIRVAL

    Marseille, 13000
    France

    Site Not Available

  • ICM, Institut régional du Cancer de Montpellier

    Montpellier, 34000
    France

    Site Not Available

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

    Nantes, 44000
    France

    Site Not Available

  • Hopital PASTEUR

    Nice, 06000
    France

    Site Not Available

  • Groupe Hospitalier Pitié Salpetriere

    Paris, 75013
    France

    Site Not Available

  • HIA du Val de Grâce

    Paris, 75005
    France

    Site Not Available

  • Hopital Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Centre Hospitalier Perpignan

    Perpignan, 49000
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, 86000
    France

    Site Not Available

  • CLCC Eugène Marquis

    Rennes, 44000
    France

    Site Not Available

  • CHU de Rouen

    Rouen, 76000
    France

    Site Not Available

  • Hôpital Nord, CHU de Saint-Etienne

    Saint-Étienne, 42000
    France

    Site Not Available

  • Institut Pul STRAUSS

    Strasbourg, 67000
    France

    Site Not Available

  • Hôpital Foch

    Suresnes, 92000
    France

    Site Not Available

  • IUCT Oncopole - CLCC Institut Claudius Regaud

    Toulouse, 31000
    France

    Site Not Available

  • CHU Bretonneau

    Tours, 37000
    France

    Site Not Available

  • CLCC Institut Gustave Roussy

    Villejuif, 94800
    France

    Site Not Available

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