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

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ClinicalTrials.gov Identifier: NCT02444000
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : January 25, 2017
Sponsor:
Collaborator:
Association de Neuro-Oncologues d’Expression Francaise
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anaplastic Gliomas With 1p/19q Codeletion Drug: PCV chemotherapy alone Drug: Radiotherapy+PCV chemotherapy Phase 3

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 31 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.
Study Start Date : June 2015
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Survival without neurocognitive deterioration [ Time Frame: 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 :
  1. progression free survival [ Time Frame: 9 years ]
  2. overall survival [ Time Frame: 9 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444000


Contacts
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Contact: Jean-Yves Delattre, MD, PhD +33(0) 1 42 16 03 85

Locations
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France
Groupe Hospitalier Pitié Salpetriere Recruiting
Paris, France, 75013
Contact: Jean-Yves Delattre, MD, PhD    +33(0) 1 42 16 03 85    jean-yves.delattre@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association de Neuro-Oncologues d’Expression Francaise
Investigators
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Principal Investigator: Jean-Yves Delattre, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02444000     History of Changes
Other Study ID Numbers: P130097
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
chemotherapy
PCV
radiotherapy
post operative treatment
 anaplastic gliomas
1p/19q codeletion
cognition
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Vincristine
Procarbazine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action