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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023956
Receipt No. R000027581
Scientific Title Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed intermediate rhabdomyosarcoma.
Date of disclosure of the study information 2016/10/01
Last modified on 2017/09/07

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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
Anticipated trial start date
2017 Year 04 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
2016 Year 09 Month 06 Day
Last modified on
2017 Year 09 Month 07 Day


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

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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