gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Association de Neuro-Oncologues d'Expression Francaise; Association de Neuro-Oncologues d’Expression Francaise

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.