JPRN-jRCTs051180200
Recruiting
Phase 2
Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma. - JRS-II LRB
Miyachi Mitsuru0 sites18 target enrollmentMarch 26, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- rhabdomyosarcoma
- Sponsor
- Miyachi Mitsuru
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), meeting criteria for low\-risk subset B.
- •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 primary tumor of CNS origin, CNS metastasis or positive CSF cytology
- •2\) patients with synchronous or metachronous concomitant malignancies
- •3\) patients with Charcot\-Marie\-Tooth disease or varicella
- •4\) prior history of chemotherapy or radiation therapy
- •5\) 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
Outcomes
Primary Outcomes
Not specified
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