gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 12, 2015

Keywords

ClinConnect Summary

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...

Gender

ALL

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.