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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025473
Receipt No. R000028899
Scientific Title Phase II study of VI (vincristine, irinotecan) / VPC (vincristine, pirarubicin, cyclophosphamide) / IE (ifosfamide, etoposide) / VAC (vincristine, actinomycin D, cyclophosphamide) for patients with newly diagnosed high-risk rhabdomyosarcoma.
Date of disclosure of the study information 2017/02/01
Last modified on 2019/07/12

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Basic information
Public title Phase II study of VI (vincristine, irinotecan) / VPC (vincristine, pirarubicin, cyclophosphamide) / IE (ifosfamide, etoposide) / VAC (vincristine, actinomycin D, cyclophosphamide) for patients with newly diagnosed high-risk rhabdomyosarcoma.
Acronym Phase II study of VI / VPC / IE / VAC for patients with newly diagnosed high-risk rhabdomyosarcoma.
Scientific Title Phase II study of VI (vincristine, irinotecan) / VPC (vincristine, pirarubicin, cyclophosphamide) / IE (ifosfamide, etoposide) / VAC (vincristine, actinomycin D, cyclophosphamide) for patients with newly diagnosed high-risk rhabdomyosarcoma.
Scientific Title:Acronym Phase II study of VI / VPC / IE / VAC for patients with newly diagnosed high-risk 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 VAC 1.2 (Vincristine, Actinomycin D, Cyclophosphamide) therapy, VI (vincristine, irinotecan) therapy and interval-compressed therapy with VPC (Vincristine, Pirarubicin, Cyclophosphamide) therapy and IE (Ifosfamide, Etoposide) therapy for patients with high-risk rhabdomyosarcoma (Stage 2, 3, Group III alveolar rhabdomyosarcoma or Stage 4, Group IV embryonal and alveolar rhabdomyosarcoma).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes incidence of progressive disease until 54 weeks
Key secondary outcomes response rate
time to treatment failure
overall survival
event free survival
frequency and grade of adverse event
cumulative days of each cycles of VPC therapy and IE therapy
cumulative dose of each chemotherapeutic agents of VPC therapy and IE therapy
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 54 weeks
VAC1.2 therapy 4cycles
vincristine 1.5mg/m2 day 1
dactinomycin 0.045mg/kg day 1
cyclophosphamide 1.2g/m2 day1
VI therapy 6 cycles
vincristine 1.5mg/m2 day 1
irinotecan 50mg/m2 day 1-5
VPC therapy 5cycles
vincristine 1.5mg/m2 day 1
pirapubicin 30mg/m2 day 1,2
cyclophosphamide 1.2g/m2 day1
IE therapy 5cycles
ifosfamide 1800mg/m2 day 1-5
etopside 100mg/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 high-risk.
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) primary central nervous system rhabdomyosarcoma, positive findings of cerebrospinal fluid cytology, metastatic central nervous system rhabdomyosarcoma
2) patients with synchronous or metachronous concomitant malignancies
3) patients with Charcot-Marie-Tooth disease or varicella
4) 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
5) patients with contraindication of drugs used in this study
6) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy
7) Patients with any other inappropriate condition judged by physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ogawa
Middle name
Last name Atsushi
Organization Niigata Cancer Center Hospital
Division name Department of Pediatrics
Zip code 951-8566
Address 2-15-3 Kawagishi-cho, Niigata-city
TEL 025-266-5111
Email atsushi@niigata-cc.jp

Public contact
Name of contact person
1st name Ogawa
Middle name
Last name Atsushi
Organization Niigata Cancer Center Hospital
Division name Department of Pediatrics
Zip code 951-8566
Address 2-15-3 Kawagishi-cho, Niigata-city
TEL 025-266-5111
Homepage URL
Email atsushi@niigata-cc.jp

Sponsor
Institute Japan Children's Cancer Group (JCCG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Ethics Review Board of Niigata Cancer Center Hospital
Address 2-15-3 Kawagishi-cho, Niigata-city 951-8566 Japan
Tel 025-266-5111
Email hosa@niigata-cc.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
2017 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2023 Year 02 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
2016 Year 12 Month 29 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028899

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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