Randomized phase III Study in patients with ANaplastic glioma of radiotherapy with Temozolomide versus nimustine hydrochloride(ACNU) followed by temozolomide (JCOG1016, SANTA study(P-III))
- Conditions
- anaplastic glioma
- Registration Number
- JPRN-UMIN000014104
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 230
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) Uncontrolled diabetes mellitus or routine administration of insulin 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 9) Interstitial pneumonia, fibroid lung, or severe lung emphysema 10) Gadolinium allergy 11) Positive HIV antibody 12) Potitive HBs antigen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method