Randomized phase III study for unresectable WHO Grade II diffuse astrocytoma with radiotherapy alone or chemoradiotherapy with temozolomide(JCOG1303, DARTS (Phase-III))
- Conditions
- WHO Grade II diffuse astrocytoma
- Registration Number
- JPRN-UMIN000014578
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 260
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method