UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017004 |
|---|---|
| Receipt number | 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 16:00:14 |
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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 | Obstetrics 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
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
mmiyachi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japan Rhabdomyosarcoma Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019647
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