gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.

Conditions
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Anaplastic Gliomas With 1p/19q Codeletion

Intervention / Treatment
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* Drug: PCV chemotherapy alone
* Drug: Radiotherapy+PCV chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>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<br>* 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<br>|
| Active Comparator: control<br>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<br>* Radiotherapy followed by 6 cycles of PCV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without neurocognitive deterioration | 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. | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 9 years | 
| overall survival |  | 9 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, PCV, radiotherapy, post operative treatment, anaplastic gliomas, 1p/19q codeletion, cognition