Phase II study of VAC1.2/VI therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.

JRCT ID: jRCTs051180200

Registered date:26/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: rhabdomyosarcoma
• Date of first enrollment: 09/07/2017
• Target sample size: 18
• Study type: Interventional

Intervention(s)

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 50mg/m2 day 1-5
surgery
radiotherapy

Outcome(s)

• Primary Outcome: event free survival

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 29age old
• Gender: Both

Include 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 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: Miyachi Mitsuru
• Source(s) of Monetary Support: Japan agency for medical research and development
• Secondary ID(s): UMIN000017004