glioblastoma
Conditions
Interventions
Arm A:
(1) Resection
(2) Chemoradiotherapy with tmozolomide (Stupp resimen)
(i) Concomitant phase, temozolomide (75 mg/m2, every day from first day to last day of radiation), radiation (60 Gy/30 fr
Sponsors
KUMABE Toshihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Suspicious as the primary glioblastoma on preoperative head contrast MRI. (2) Judged that resection of more than 90% of contrast region on head contrast MRI can be achieved. (3) No history of resection including biopsy for glioma. In case who diagnosed as glioblastoma after the first resection (partly resection or biopsy), all of the following conditions must be fulfilled: (i) Resection of more than 90% of contrast region will be performed at the institutions in JCOG study groups of the Brain Tumor Study Group within 3 weeks from the first resection. (ii) Preoperative head contrast MRI before first resection is available. (iii) Negative of immunostaining of IDH1 if performed. (4) The tumor exists in the cerebrum and diencephalon on preoperative head contrast MRI and no evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and pituitary gland. (5) Preoperative head contrast MRI revealed no multiple legions or dissemination. (6) Aged 20 to 75 years old at registration. (7) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor. (8) No prior chemotherapy or head radiation therapy for any malignant diseases (9) Sufficient organ function. (i) Neutrophil count >= 1,500 /mm3 (ii) Hemoglobin >= 8.0 mg/dl (iii) Platelet count >= 100,000 /mm3 (iv) AST =< 120 U/L (v) ALT =< 120 U/L (vi) Cr =< 1.5 mg/dL (10) Written informed consent. Second registration (intraoperative) criteria (1) Within 14 days of the first registration (2) Diagnosed as glioblastoma or Grade III glioma (WHO 2016 edition) in pathological diagnosis during surgery. (3) Judged as achievement of resection of more than 90% of the tumor. Intra MRI is not mandatory.
Exclusion criteria
Exclusion criteria: (1) Synchronous or metachronous (within 2 years) malignancies (2) Infections which needs systemic treatment. (3) Body temperature is higher than 38 degrees centigrade at registration. (4) Female during pregnancy, within 28 days of postparturition, or during lactation. (5) Severe psychological disease. (6) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor. (7) Uncontrollable diabetes mellitus. (8) Unstable angina pectoris, or history of myocardial infarction within 6 months. (9) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p. (10) Gadolinium allergy. (11) Positive HIV antibody. (12) Positive HBs antigen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Loco-regional progression-free survival, Proportion of adverse events | — |
Contacts
Public ContactToshihiro KUMABE
Kitasato University Hospital
Outcome results
None listed