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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039049
Receipt No. R000044529
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.
Date of disclosure of the study information 2020/01/10
Last modified on 2020/01/03

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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