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

JRCT ID: jRCTs051180208

Registered date:27/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rhabdomyosarcoma
• Date of first enrollment: 01/06/2017
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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
irinotecan 50mg/m2 day 1-5
VPC therapy 5cycles
vincristine 1.5mg/m2 day 1
pirapubicin 30mg/m2 day 1,2
cyclophosphamide 1.2g/m2 day1
IE therapy 5cycles
ifosfamide 1800mg/m2 day 1-5
etopside 100mg/m2 day 1-5
surgery
radiotherapy

Outcome(s)

• Primary Outcome: incidence of progressive disease until 54 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: <= 29age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ogawa Atsushi
• Source(s) of Monetary Support: Japan agency for medical research and development
• Secondary ID(s): UMIN000025473