Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.

Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma. - Phase II study of VAC1.2/VI therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017004

Enrollment

Registered

2016-02-01

Start date

2016-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rhabdomyosarcoma

Interventions

chemotherapy 43 weeks VAC1.2 therapy 9 cycles vincristine 1.5mg/m2 day 1 dactinomycin 0.045mg/kg day 1 cyclophosphamide 1.2g/m2 day1 VI therapy 5 cycles vincristine 1.5mg/m2 day 1 irinotecan 50

Eligibility

Sex/Gender

All

Inclusion 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 first surgery. 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

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 5) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy 6) Patients with any other inappropriate condition judged by physician

Design outcomes

Primary

Measure	Time frame
event free survival	—

Secondary

Measure	Time frame
overall survival time to treatment failure overall response rate frequency and grade of adverse event 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	—

Countries

Japan

Contacts

Public ContactMitsuru Miyachi

Graduate School of Medical Science, Kyoto Prefectural University of Medicine Department of Pediatrics

mmiyachi@koto.kpu-m.ac.jp075-251-5571

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026