JPRN-UMIN000025473
Completed
Phase 2
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. - Phase II study of VI / VPC / IE / VAC for patients with newly diagnosed high-risk rhabdomyosarcoma.
Japan Children's Cancer Group (JCCG)0 sites60 target enrollmentFebruary 1, 2017
Conditionsrhabdomyosarcoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- rhabdomyosarcoma
- Sponsor
- Japan Children's Cancer Group (JCCG)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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