gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

  • STATUS
    Recruiting
  • End date
    Jun 21, 2024
  • participants needed
    280
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 21 January 2021

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.

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.

Details
Condition Anaplastic Gliomas With 1p/19q Codeletion, Anaplastic Gliomas With 1p/19q Codeletion
Treatment PCV chemotherapy alone, Radiotherapy+PCV chemotherapy
Clinical Study IdentifierNCT02444000
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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
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