UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of VAC2.2(vincristine, actinomycin-D, cyclophosphamide)/ VA(vincristine, actinomycin-D) therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Acronym	Phase II study of VAC2.2/VA therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Scientific Title	Phase II study of VAC2.2(vincristine, actinomycin-D, cyclophosphamide)/ VA(vincristine, actinomycin-D) therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Scientific Title:Acronym	Phase II study of VAC2.2/VA therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Region	Japan

Condition
Condition	rhabdomyosarcoma
Classification by specialty	Hematology and clinical oncology Surgery in general Obsterics and gynecology Pediatrics Ophthalmology Dermatology Oto-rhino-laryngology Orthopedics Urology Radiology Oral surgery Neurosurgery Plastic surgery Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Determine the safety and efficacy of VAC2.2 (vincristine, actinomycin-D, cyclophosphamide)/VA (vincristine, actinomycin-D) therapy and/or radiation therapy for patients with low-risk subset A rhabdomyosarcoma stratified by IRS-V risk classification.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Event free survival
Key secondary outcomes	overall survival time to treatment failure response rate of chemotherapy (for group III patients) frequency of adverse event

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 48 weeks VAC2.2 therapy 8 cycles vincristine 1.5mg/m2 day 1 dactinomycin 0.045mg/kg day 1 cyclophosphamide 2.2g/m2 day1 VAC1.2 therapy 8 cycles vincristine 1.5mg/m2 day 1 dactinomycin 0.045mg/kg day 1 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	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), meeting criteria for low-risk subset B by IRS-V classification. 2) Age younger than 19 years old. 3) Initiation of chemotherapy within 42 days after first surgery. 4) No prior history of malignancy. 5) ECOG 0-3 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 prior history of chemotherapy 3) patients with prior history of radiation therapy 4) Female patients who are pregnant or breastfeeding mother 5) patients with contraindication of drugs used in this study 6) patients with Charcot-Marie-Tooth disease, varicella or pentostatin medication 7) Patients with any other inappropriate condition judged by physician
Target sample size	41

Research contact person
Name of lead principal investigator	1st name Hajime Middle name Last name Hosoi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pediatrics, Graduate School of Medical Science
Zip code	602-8566
Address	465 Kajii-cho, Kwaramachi-Hirokoji, Kyoto
TEL	075-251-5571
Email	hhosoi@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Mitsuru Middle name Last name Miyachi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pediatrics, Graduate School of Medical Science
Zip code	602-8566
Address	465 Kajii-cho, Kwaramachi-Hirokoji, Kyoto
TEL	075-251-5571
Homepage URL
Email	mmiyachi@koto.kpu-m.ac.jp

Sponsor
Institute	Japan Rhabdomyosarcoma Study Group
Institute
Department

Funding Source
Organization	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	Kyoto Prefectural University of Medicine
Address	465 Kajii-cho, Kwaramachi-Hirokoji, Kyoto
Tel	075-251-5111
Email	rinri@koto.kpu-m.ac.jp

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	2020 Year 01 Month 10 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	16
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	Completed
Date of protocol fixation	2004 Year 04 Month 01 Day
Date of IRB	2004 Year 04 Month 23 Day
Anticipated trial start date	2004 Year 05 Month 01 Day
Last follow-up date	2020 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 03 Day
Last modified on	2020 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044529