A randomized phase II/III study of ACNU versus Procarbazine plus ACNU as a postoperative chemoradiotherapy for strocytoma grade 3 and 4(JCOG0305, ACNU+PCZ PhaseII/III)
Phase 2
- Conditions
- astrocytoma grade 3/4
- Registration Number
- JPRN-C000000108
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 310
Inclusion Criteria
Not provided
Exclusion Criteria
1. Synchronous double cancer or metachronous double cancer in last 5 years; carcinoma in situ accepted 2. Meningitis or pneumonia 3. Pregnant, possibly pregnant or nursing women 4. Mental disorder 5. Uncontrollable diabetes mellitus or DM under treatment with Insulin 6. Myocardial infarction in last 3 months 7. History of pulmonary fibrosis or interstitial pneumonia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endpoint in phase II stage: 6 months survival Endpoint in phase III stage: Overall survival (OS)
- Secondary Outcome Measures
Name Time Method Endpoint in phase II stage: Overall survival (OS) Endpoint in phase III stage: Progression free survival (PFS) ,Response rate (RR), % complete response (%CR),Toxicity