WHO Grade II diffuse astrocytoma
Conditions
Interventions
Arm A: Radiotherapy alone (50.4 Gy/28 fr, 5 days/week)
Arm B: Concomitant phase, temozolomide (75 mg/m2, every day from first day to last day of radiation), radiation (50.4 Gy/28 fr, 5 days/week) Mai
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven WHO Grade II astrocytoma (diffuse astrocytoma, fibrillary astrocytoma, protoplasmic astrocytoma, gemistocytic astrocytoma) For those who had additional surgery, he/she must meet a) or b). a) diagnosed with WHO Grade II astrocytoma after both primary and addtional surgeries. b) undiagnosed after ptimary surgery and diagnosed with WHO Grade II astrocytoma after additional surgery. 2) No history of previous therapy for tumor except craniotomy or biopsy (newly diagnosed tumor). Those who underwent additional surgery within 84 days after primary surgery are eligible. 3) No clinically systemic metastasis (Imaging study except chest X-ray is not mandatory). 4) 50% or more of the tumor existing in the cerebrum and diencephalon. 5) Postoperative MRI within 42 days after surgery revealed residual tumor. (A) Tumor resection < 90% (B) Tumor resection >=90% and <100%, and classified as high risk by EORTC low grade glioma score *EORTC LGG score high risk includes at least three of the following conditions. (1) age >= 40 years (2) largest diameter of the tumor >= 60 mm (3) tumor crossing the midline (4) astrocytoma histology subtype (5) presence of neurologic deficit 6) Preoperative MRI revealed no multiple legions or dissemination. 7) Preoperative and postoperative MRI revealed measurable or non-measurable disease. 8) Three to 42 days after surgery. 9) Aged 20 to 69 years old at registration. 10) KPS(Karnofsky performance status)of 70-100. 11) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is acceptable. 12) Adequate organ function. 13) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Active infectious meningitis 4) Body temperature >= 38 degrees Celsius at registration 5) Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding 6) Psychosis or with psychotic symptom 7) Continuous systemic use of steroid or immunosuppressant for disease except for brain tumor 8) Uncontrolled diabetes mellitus or routine administration of insulin 9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 10) Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema 11) Gadolinium allergy 12) Positive HIV antibody 13) Potitive HBs antigen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Response rate, Complete response rate, Completion of therapy , Adverse events, Serious adverse events | — |
Countries
Japan
Contacts
Public ContactYasuji Miyakita
JCOG1303 Coordinating Office National Cancer Center Central Hospital, Department of Neurosurgery and Neuro-Oncology
Outcome results
None listed