Phase II study of VAC1.2(vincristine, actinomycin-D, cyclophosphamide) therapy for patients with newly diagnosed low-risk subset A rhabdomyosarcoma.

Phase II study of VAC1.2(vincristine, actinomycin-D, cyclophosphamide) therapy for patients with newly diagnosed low-risk subset A rhabdomyosarcoma. - Phase II study of VAC1.2 therapy for patients with newly diagnosed low-risk subset A rhabdomyosarcoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039048

Enrollment

Registered

2020-01-10

Start date

2004-05-01

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 24 weeks VAC1.2 therapy 8 cycles vincristine 1.5mg/m2 day 1 dactinomycin 0.045mg/kg day 1 cyclophosphamide 1.2g/m2 day1 surgery radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), meeting criteria for low-risk subset A by IRS-V classification. 2) Age younger than 19 years old. 3) Initiation of chemotherapy within 42 days after first surgery. 4) No prior history of malignancy. 5) ECOG 0-3 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 prior history of chemotherapy 3) patients with prior history of radiation therapy 4) Female patients who are pregnant or breastfeeding mother 5) patients with contraindication of drugs used in this study 6) patients with Charcot-Marie-Tooth disease, varicella or pentostatin medication 7) 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 response rate of chemotherapy (for group III orbit patients) frequency of adverse event	—

Countries

Japan

Contacts

Public ContactMitsuru Miyachi

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

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

Outcome results

None listed

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