Anaplastic Gliomas With 1p/19q Codeletion
Conditions
Keywords
chemotherapy, PCV, radiotherapy, post operative treatment, anaplastic gliomas, 1p/19q codeletion, cognition
Brief 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.
Detailed 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.
Interventions
DRUGPCV chemotherapy alone
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
DRUGRadiotherapy+PCV chemotherapy
Radiotherapy followed by 6 cycles of PCV
Sponsors
Assistance Publique - Hôpitaux de Paris
Association de Neuro-Oncologues d'Expression Francaise
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival without neurocognitive deterioration | 9 years | 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. |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival | 9 years |
| overall survival | 9 years |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCaroline DEHAIS, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed