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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Anaplastic Gliomas With 1p/19q Codeletion

Treatments: Drug: Radiotherapy+PCV chemotherapy; Drug: PCV chemotherapy alone

Study type: Interventional

Funder types: Other

Identifiers

NCT02444000

P130917

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

experimental

Experimental group

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

Treatment:

Drug: PCV chemotherapy alone

control

Active Comparator group

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

Treatment:

Drug: Radiotherapy+PCV chemotherapy