Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Inclusion Criteria61

• Pre-Registration
• This review is mandatory prior to registration to confirm eligibility; patients must
• be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible
• Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review
• Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility,
• the 1p/19q analysis results will be accepted from the local site, as determined
• by either a locally available or reference laboratory; acceptable methods for
• determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by
• genomic sequencing or methylomic analyses;
• Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic
• analyses; this should be performed at the local site
• Registration
• Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as
• long as the patient has not received prior radiation or prior chemotherapy
• Histological evidence of World Health Organization (WHO) grade III anaplastic glioma
• or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced
• laboratory qualified for the study
• Note: mixed gliomas are eligible, regardless of the degree of astrocytic or
• oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q
• Patients with codeleted low grade gliomas must also be considered "high risk" by
• exhibiting one or more of the following characteristics:
• Age >= 40 and any surgical therapy
• Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than
• gross total resection)
• Documented growth following prior surgery (NOTE: patients with prior surgery
• cannot have received prior radiation, chemotherapy or targeted therapy)
• Intractable seizures
• Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks
• prior to registration; patient must have recovered adequately from the effects of
• surgery
• Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to
• registration
• Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration
• Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days
• prior to registration
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3
• x ULN obtained =< 21 days prior to registration
• Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration
• Negative serum or urine pregnancy test done =< 7 days prior to registration, for women
• of childbearing potential only
• Willingness and ability to personally complete neurocognitive testing (without
• assistance) and willingness to complete the QOL testing, (either personally or with
• assistance)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
• Written informed consent
• Willingness to return to enrolling institution for follow-up during the active
• monitoring phase (that is, the active treatment and observation portion) of the
• study); patients who have been formally transferred to another active and approved
• site participating in this study would not need to return to the enrolling institution
• for this purpose
• Willingness to allow the provision of tissue samples for correlative research, as long
• as adequate tissues are available; patients will not be excluded from participation in
• the study, if they are willing to allow provision of tissues for the correlative
• research, but there are insufficient quantities of tissue for the correlative analyses
• (e.g., a patient otherwise eligible and willing who had biopsy only) Willingness to
• allow the provision of blood samples for correlative research; patients are not
• excluded from participation in the study, if they are willing to provide the mandatory
• biospecimens for translational/correlative research, but for logistical reasons the
• specimens(s) were not obtainable or if the volume collected was insufficient
• Registration