gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas (NCT02444000) | Clinical Trial Compass
CompletedPhase 3
gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas
France280 participantsStarted 2015-09-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.