A Multicenter Randomized Phase II trial of Interferon-beta and Temozolomide Combination Chemoradiotherapy for Newly Diagnosed Glioblastomas(JCOG0911, INTEGRA study (P-II))
Phase 2
- Conditions
- Glioblastoma
- Registration Number
- JPRN-UMIN000003466
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within the past 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Infection with systemic therapy indicated 3) fever over 38 degrees Celsius 4) Active infectious meningitis 5) Women during pregnancy, possible pregnancy or breast-feeding 6) Psychosis 7) Uncontrollable diabetes mellitus or administration of insulin 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 9) Interstitial pneumonia, or fibroid lung 10) Patients who can 't receive gadolinium
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method progression-free survival, complete response rate, response rate, adverse events