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

Primary Purpose

Anaplastic Gliomas With 1p/19q Codeletion

Status
Active
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
PCV chemotherapy alone
Radiotherapy+PCV chemotherapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Gliomas With 1p/19q Codeletion focused on measuring chemotherapy, PCV, radiotherapy, post operative treatment, anaplastic gliomas, 1p/19q codeletion, cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU d'Amiens- CHU nord
  • CHU D'Anger
  • CHU annecy genevois
  • CHU de Bordaux
  • Hopital de la Cavale Blanche
  • CHU de Caen
  • Hopital Gabriel Montpied
  • CH Louis Pasteur
  • Hopital François Mitterand
  • CHU Sud Réunion
  • Hopital Roger Salengro
  • Chu Dupuytren
  • Centre Hospitalier de Bretagne Sud - Hôpital du Scorff
  • GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
  • Hôpital Pierre Wertheimer
  • CHU la Timone
  • Hopital CLAIRVAL
  • ICM, Institut régional du Cancer de Montpellier
  • Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau
  • Hopital PASTEUR
  • HIA du Val de Grâce
  • Hopital Saint Louis
  • Groupe Hospitalier Pitié Salpetriere
  • Centre Hospitalier Perpignan
  • CHU de Poitiers
  • CLCC Eugène Marquis
  • CHU de Rouen
  • Hôpital Nord, CHU de Saint-Etienne
  • Institut Pul STRAUSS
  • Hôpital Foch
  • IUCT Oncopole - CLCC Institut Claudius Regaud
  • CHU Bretonneau
  • CLCC Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

progression free survival
overall survival

Full Information

First Posted
May 12, 2015
Last Updated
October 24, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association de Neuro-Oncologues d'Expression Francaise
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1. Study Identification

Unique Protocol Identification Number
NCT02444000
Brief Title
gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas
Acronym
POLCA
Official Title
A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2015 (Actual)
Primary Completion Date
September 21, 2024 (Anticipated)
Study Completion Date
September 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association de Neuro-Oncologues d'Expression Francaise

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Gliomas With 1p/19q Codeletion
Keywords
chemotherapy, PCV, radiotherapy, post operative treatment, anaplastic gliomas, 1p/19q codeletion, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PCV chemotherapy alone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Radiotherapy+PCV chemotherapy
Intervention Description
Radiotherapy followed by 6 cycles of PCV
Primary Outcome Measure Information:
Title
Survival without neurocognitive deterioration
Description
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.
Time Frame
9 years
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
9 years
Title
overall survival
Time Frame
9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline DEHAIS, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens- CHU nord
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CHU D'Anger
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHU annecy genevois
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
CHU de Bordaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
30000
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CH Louis Pasteur
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Hopital François Mitterand
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU Sud Réunion
City
La Réunion
ZIP/Postal Code
97000
Country
France
Facility Name
Hopital Roger Salengro
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Chu Dupuytren
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Centre Hospitalier de Bretagne Sud - Hôpital du Scorff
City
Lorient
ZIP/Postal Code
56000
Country
France
Facility Name
GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hôpital Pierre Wertheimer
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
CHU la Timone
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Hopital CLAIRVAL
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
ICM, Institut régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital PASTEUR
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
HIA du Val de Grâce
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Groupe Hospitalier Pitié Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Hospitalier Perpignan
City
Perpignan
ZIP/Postal Code
49000
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CLCC Eugène Marquis
City
Rennes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Hôpital Nord, CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France
Facility Name
Institut Pul STRAUSS
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92000
Country
France
Facility Name
IUCT Oncopole - CLCC Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
CHU Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CLCC Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

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