JPRN-jRCTs051180207
Recruiting
Phase 2
Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed intermediate rhabdomyosarcoma. - Phase II study of VAC2.2/VI therapy for patients with newly diagnosed intermediate rhabdomyosarcoma.
Hosono Ako0 sites40 target enrollmentMarch 27, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hosono Ako
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically confirmed newly diagnosed rhabdomyosarcoma (RMS), meeting criteria for intermediate.
- •2\) Age younger than 30 years old.
- •3\) Initiation of chemotherapy within 42 days after pathological diagnosis.
- •4\) No prior history of malignancy.
- •5\) ECOG 0\-2 (\>\=16 years old) or Lansky 50\-100% (\< 16 years old)
- •6\) Patients must have sufficient organ function.
- •7\) All patients and/or their parents or legal guardians must sign a written informed consent.
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
Outcomes
Primary Outcomes
Not specified
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