glioblastoma
Conditions
Interventions
Group A: Standard treatment group [GTR (complete resection of the contrast-enhanced lesion) + concomitant chemoradiotherapy with temozolomide] / Group B: Experimental treatment group [FLAIRectomy (com
Sponsors
SONODA Yukihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The preoperative cranial contrast-enhanced MRI satisfies all of the following criteria (a) through (c): (a) The presence of suspected primary glioblastoma. (b) The tumor is located supratentorial (in the cerebrum or diencephalon) and is not found in the cerebellum, brainstem, optic nerves, olfactory nerves, or pituitary gland. (c) There is no evidence of multiple lesions or dissemination. (2) Surgical resection can be performed without worsening the significant neurological symptoms, fulfilling all the following criteria (a) through (c) (a) The predicted resection rate of the contrast-enhanced lesion is at least 95%. (b) When performing a FLAIRectomy, the predicted resection rate of the FLAIR hyperintense lesion is at least 20%. (c) When performing a GTR (complete resection of the contrast-enhanced lesion), the predicted resection rate of the FLAIR hyperintense lesion is less than 20%. (3) No prior tumor resection, including biopsy, for glioma has been performed. (4) The patient's age at registration is between 18 and 75 years old. (5) The Performance Status (PS) is either 0-2 according to ECOG criteria or PS 3 solely due to tumor-related neurological symptoms (PS must be documented in the medical record). (6) There is no history of chemotherapy or radiotherapy to the head for any cancer. (7) The most recent test results within 14 days prior to registration (the same day of the week, two weeks before registration is acceptable) meet all of the following criteria (a) through (f) (a) Neutrophil count >= 1,500/mm3 (b) Hemoglobin >= 8.0 g/dL (c) Platelet count >= 10 x 104/mm3 (d) AST <= 120 U/L (e) ALT <= 120 U/L (f) Serum creatinine <= 1.5 mg/dL (8) Written consent has been obtained from the patient to participate in the study. However, suppose the patient can understand and agree to the explanation content but is unable to sign due to neurological symptoms. In that case, a proxy may sign the consent form on behalf of the patient.
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) Severe psychological disease. (5) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor. (6) Uncontrollable diabetes mellitus. (7) Unstable angina pectoris, or history of myocardial infarction within 6 months. (8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p. (9) Gadolinium allergy. (10) Positive HIV antibody. (11) Positive HBs antigen. (12) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. Men who wish for their partners to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Local progression-free survival, Proportion of adverse events, Proportion of surgical adverse events, Proportion of Karnofsky Performance Status (KPS) preservation, Proportion of National Institute of Health Stroke Scale (NIHSS) preservation, Proportion of Mini Mental Status Examination (MMSE) preservation, Proportion of Health-related Quality of Life (QOL) preservation | — |
Contacts
Public ContactYuta MITOBE
Yamagata Univertisy Hospital
Outcome results
None listed