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 (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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025473

Enrollment

Registered

2017-02-01

Start date

2017-02-01

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 54 weeks VAC1.2 therapy 4cycles vincristine 1.5mg/m2 day 1 dactinomycin 0.045mg/kg day 1 cyclophosphamide 1.2g/m2 day1 VI therapy 6 cycles vincristine 1.5mg/m2 day 1 irinote

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed newly diagnosed rhabdomyosarcoma (RMS), meeting criteria for high-risk. 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) 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

Design outcomes

Primary

Measure	Time frame
incidence of progressive disease until 54 weeks	—

Secondary

Measure	Time frame
response rate time to treatment failure overall survival event free survival frequency and grade of adverse event cumulative days of each cycles of VPC therapy and IE therapy cumulative dose of each chemotherapeutic agents of VPC therapy and IE therapy 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	—

Measure

Time frame

response rate time to treatment failure overall survival event free survival frequency and grade of adverse event cumulative days of each cycles of VPC therapy and IE therapy cumulative dose of each chemotherapeutic agents of VPC therapy and IE therapy 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 ContactOgawa Atsushi

Niigata Cancer Center Hospital Department of Pediatrics

atsushi@niigata-cc.jp025-266-5111

Outcome results

None listed

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