Phase II study of VI / VPC / IE / VAC for patients with newly diagnosed high-risk rhabdomyosarcoma.

Phase 2

Recruiting

• Conditions: Rhabdomyosarcoma; D012208

• Registration Number: JPRN-jRCTs051180208
• Lead Sponsor: Ogawa Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Histologically confirmed newly diagnosed Stage 2, 3 and Group III alveolar rhabdomyosarcoma (RMS), meeting criteria for high-risk.
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
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