gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas (POLCA)

A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anaplastic Gliomas With 1p/19q Codeletion
• Intervention / Treatment: Drug: PCV chemotherapy alone; Drug: Radiotherapy+PCV chemotherapy

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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • CHU d'Amiens- CHU nord
  • Angers, France, 49000
    • CHU D'Anger
  • Annecy, France, 74000
    • CHU annecy genevois
  • Bordeaux, France, 33000
    • CHU de Bordaux
  • Brest, France, 29000
    • Hopital De La Cavale Blanche
  • Caen, France, 30000
    • CHU de Caen
  • Clermont-Ferrand, France, 63000
    • Hopital Gabriel Montpied
  • Colmar, France, 68000
    • CH Louis Pasteur
  • Dijon, France, 21000
    • Hopital Francois Mitterand
  • La Réunion, France, 97000
    • CHU Sud Réunion
  • Lille, France, 59000
    • Hôpital Roger Salengro
  • Limoges, France, 87000
    • Chu Dupuytren
  • Lorient, France, 56000
    • Centre Hospitalier de Bretagne Sud - Hopital du Scorff
  • Lyon, France, 69000
    • GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
  • Lyon, France, 69000
    • Hôpital Pierre Wertheimer
  • Marseille, France, 13000
    • CHU La Timone
  • Marseille, France, 13000
    • Hôpital Clairval
  • Montpellier, France, 34000
    • ICM, Institut régional du Cancer de Montpellier
  • Nantes, France, 44000
    • Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau
  • Nice, France, 06000
    • Hopital Pasteur
  • Paris, France, 75010
    • Hôpital Saint Louis
  • Paris, France, 75005
    • Hia Du Val De Grace
  • Paris, France, 75013
    • Groupe Hospitalier Pitié Salpêtrière
  • Perpignan, France, 49000
    • Centre Hospitalier Perpignan
  • Poitiers, France, 86000
    • Chu de Poitiers
  • Rennes, France, 44000
    • CLCC Eugène Marquis
  • Rouen, France, 76000
    • CHU de Rouen
  • Saint-Étienne, France, 42000
    • Hôpital Nord, CHU de Saint-Etienne
  • Strasbourg, France, 67000
    • Institut Pul STRAUSS
  • Suresnes, France, 92000
    • Hopital Foch
  • Toulouse, France, 31000
    • IUCT Oncopole - CLCC Institut Claudius Regaud
  • Tours, France, 37000
    • CHU Bretonneau
  • Villejuif, France, 94800
    • CLCC Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
Active Comparator: control; 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; Radiotherapy followed by 6 cycles of PCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
progression free survival	9 years
overall survival	9 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Association de Neuro-Oncologues d'Expression Francaise
• Investigators: Principal Investigator: Caroline DEHAIS, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2015
• Primary Completion (Anticipated): September 21, 2024
• Study Completion (Anticipated): September 21, 2024

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: chemotherapy; radiotherapy; cognition; PCV; post operative treatment; anaplastic gliomas; 1p/19q codeletion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: P130097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No