Phase II study of VAC1.2/VI therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
- Conditions
- rhabdomyosarcomaD012208
- Registration Number
- JPRN-jRCTs051180200
- Lead Sponsor
- Miyachi Mitsuru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
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.
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
Renal failure
6) patients with contraindication of drugs used in this study
7) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy
8) 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 <br>time to treatment failure <br>overall response rate <br>frequency and grade of adverse event <br>frequency and grade of irinotecan-related adverse event in relation with UGT1A1 gene polymorphism <br>diagnostic and prognostic significance of serum miR-206 value <br>quality control of radiation therapy