UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed intermediate rhabdomyosarcoma.
Acronym	Phase II study of VAC2.2/VI therapy for patients with newly diagnosed intermediate rhabdomyosarcoma.
Scientific Title	Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed intermediate rhabdomyosarcoma.
Scientific Title:Acronym	Phase II study of VAC2.2/VI therapy for patients with newly diagnosed intermediate rhabdomyosarcoma.
Region	Japan

Condition
Condition	rhabdomyosarcoma
Classification by specialty	Hematology and clinical oncology Obsterics and gynecology Pediatrics Oto-rhino-laryngology Orthopedics Urology Neurosurgery Plastic surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Determine the safety and efficacy of VAC 2.2 (vincristine, actinomycin-D, cyclophosphamide) therapy and VI (vincristine and irinotecan) therapy for patients with intermediate rhabdomyosarcoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Event free survival
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	chemotherapy 43 weeks VAC1.2 therapy 1 cycles vincristine 1.5mg/m2 day 1 dactinomycin 0.045mg/kg day 1 cyclophosphamide 1.2g/m2 day1 VAC2.2 therapy 8 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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	30 years-old >
Gender	Male and Female
Key inclusion criteria	1) 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 first surgery. 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.
Key exclusion criteria	1) 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
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ako Hosono
Organization	National Cancer Center Hospital East
Division name	Division of Pediatric Oncology
Zip code
Address	6-5-1 Kashiwanoha Kashiwa-shi Chiba
TEL	04-7133-1111
Email	ahosono@east.ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Ako Hosono
Organization	National Cancer Center Hospital East
Division name	Division of Pediatric Oncology
Zip code
Address	6-5-1 Kashiwanoha Kashiwa-shi Chiba
TEL	04-7133-1111
Homepage URL
Email	ahosono@east.ncc.go.jp

Sponsor
Institute	Japan Rhabdomyosarcoma Study Group
Institute
Department

Funding Source
Organization	Grant for innovative clinical cancer research from the Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 20 Day
Date of IRB	2019 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2020 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027581