Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed intermediate rhabdomyosarcoma.
Not Applicable
Recruiting
- Conditions
- rhabdomyosarcoma
- Registration Number
- JPRN-UMIN000023956
- Lead Sponsor
- Japan Rhabdomyosarcoma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients with synchronous or metachronous concomitant malignancies 2) patients with Charcot-Marie-Tooth disease or varicella 3) patients with uncontrollable complications Interstitial pneumonia, pulmonary fibrosis, severe emphysema Uncontrollable diabetes mellitus Uncontrollable hypertension Severe electrocardiogram abnormality or clinically significant heart disease(heart failure, myocardial infarction, angina pectoris) Liver failure, cirrhosis Renal failure 4) patients with contraindication of drugs used in this study 5) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy 6) Patients with any other inappropriate condition judged by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event free survival
- Secondary Outcome Measures
Name Time Method overall survival time to treatment failure overall response rate frequency and grade of adverse event frequency and grade of irinotecan-related adverse event in relation with UGT1A1 gene polymorphism diagnostic and prognostic significance of serum miR-206 value quality control of radiation therapy