NIPH Clinical Trials Search

JRCT ID: jRCTs051180207

Registered date:27/03/2019

Phase II study of VAC2.2/VI therapy for patients with newly diagnosed intermediate rhabdomyosarcoma

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedRhabdomyosarcoma
Date of first enrollment19/02/2018
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)chemotherapy 43 weeks VAC2.2 therapy 9 cycles vincristine 1.5mg/m2 day 1 dactinomycin 0.045mg/kg day 1 cyclophosphamide 2.2g/m2 day1 VI therapy 5 cycles vincristine 1.5mg/m2 day 1 irinotecan 50mg/m2 day 1-5 surgery radiotherapy


Primary Outcomeevent free survival
Secondary Outcomeoverall 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>= 1age old
Age maximum<= 29age old
Include criteria1) Histologically confirmed newly diagnosed rhabdomyosarcoma (RMS), meeting criteria for intermediate. 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 criteria1) patients with synchronous or metachronous concomitant malignancies 2) patients with Charcot-Marie-Tooth disease or varicella 3) 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 4) patients with contraindication of drugs used in this study 5) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy 6) Patients with any other inappropriate condition judged by physician

Related Information


Public contact
Name Mitsuru Miyachi
Address 465 Kajii-cho, Kawamachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN Kyoto Japan 602-8566
Telephone +81-75-251-5571
Affiliation University Hospital, Kyoto Prefectural University of Medicine
Scientific contact
Name Ako Hosono
Address 6-5-1 Kashiwanoha, Kashiwa-shi,Chiba JAPAN Chiba Japan 277-8577
Telephone +81-4-7133-1111
Affiliation National Cancer Center Hospital East