Phase II study of VI (vincristine, irinotecan) / VPC (vincristine, pirarubicin, cyclophosphamide) / IE (ifosfamide, etoposide) / VAC (vincristine, actinomycin D, cyclophosphamide) for patients with newly diagnosed high-risk rhabdomyosarcoma.
- Conditions
- rhabdomyosarcoma
- Registration Number
- JPRN-UMIN000025473
- Lead Sponsor
- Japan Children's Cancer Group (JCCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
1) primary central nervous system rhabdomyosarcoma, positive findings of cerebrospinal fluid cytology, metastatic central nervous system rhabdomyosarcoma 2) patients with synchronous or metachronous concomitant malignancies 3) patients with Charcot-Marie-Tooth disease or varicella 4) 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 5) patients with contraindication of drugs used in this study 6) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy 7) Patients with any other inappropriate condition judged by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of progressive disease until 54 weeks
- Secondary Outcome Measures
Name Time Method response rate time to treatment failure overall survival event free survival frequency and grade of adverse event cumulative days of each cycles of VPC therapy and IE therapy cumulative dose of each chemotherapeutic agents of VPC therapy and IE therapy 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