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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017004
Receipt No. R000019647
Scientific Title Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Date of disclosure of the study information 2016/02/01
Last modified on 2016/02/10

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Basic information
Public title Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Acronym Phase II study of VAC1.2/VI therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Scientific Title Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Scientific Title:Acronym Phase II study of VAC1.2/VI therapy for patients with newly diagnosed low-risk subset B rhabdomyosarcoma.
Region
Japan

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

Objectives
Narrative objectives1 Determine the safety and efficacy of VAC1.2 (vincristine, actinomycin-D, cyclophosphamide) therapy and VI (vincristine and irinotecan) therapy for patients with low-risk subset B rhabdomyosarcoma (Stage 1, Group III except Group III, N0, N1, orbit primary or Stage 3, Group I, II).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

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 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
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 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 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 18

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

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Miyachi
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Pediatrics
Zip code
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 Grant for innovative clinical cancer research from the Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
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 02 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 01 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 01 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019647

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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