UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004700 |
|---|---|
| Receipt number | R000005582 |
| Scientific Title | A phase 2 study of the decision of surgical adjustment time based on IDRF (Image Defined Risk Factors), and chemotherapy that gradually improve strength for intermediate risk neuroblastoma |
| Date of disclosure of the study information | 2010/12/09 |
| Last modified on | 2014/12/09 10:11:44 |
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Basic information
Public title
A phase 2 study of the decision of surgical adjustment time based on IDRF (Image Defined Risk Factors), and chemotherapy that gradually improve strength for intermediate risk neuroblastoma
Acronym
A phase 2 study of the operation based on IDRF and chemotherapy for intermediate risk neuroblastoma
Scientific Title
A phase 2 study of the decision of surgical adjustment time based on IDRF (Image Defined Risk Factors), and chemotherapy that gradually improve strength for intermediate risk neuroblastoma
Scientific Title:Acronym
A phase 2 study of the operation based on IDRF and chemotherapy for intermediate risk neuroblastoma
Region
| Japan |
Condition
Condition
intermediate risk neuroblastomas
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objective of the study is to investigate efficacy and safety of the operation based on IDRF and chemotherapy for intermediate risk neuroblastoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3 years progression-free survival rates
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were given induction therapy LI-B (vincristine 1.5mg/m2 and cyclophosphamide 600mg/m2on day 1, pirarubicin 30mg/m2 on day 3) or LI-C (vincristine 1.5mg/m2, cyclophosphamide 900mg/m2 and carboplatin450mg/m2 on day 1). and were evaluated of possibility of surgical resection every three courses. When the effect is insufficient, it changes to stronger regemen(LI-D/E).
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)age;day0-18 years old
(2)diagnosis;histologically confirmed neuroblastoma or ganglioneuroblastoma by biopsy sample of primary tumor or metastatic tumor (include bone marrow). However, if the urine VMA and HVA (tumor marker) increase and MIBG scintigraphy are positivities, when the biopsy is difficult because of patient's condition, the patients can be diagnosed as the neuroblastoma.
(3)staging and prognostic factors
stage 3 (12months<= and Favorable Histology,12-18months and Unfavorable Histology) MYCN gene not amplification
stage 4(12 months>, 12-18months and Favorable Histology and DNA index>1) MYCN gene not amplification
stage 4S(Unfavorable Histology or Favorable Histology and DNA index=1) MYCN gene not amplification
(4) no pre-emptive chemotherapy or radiotherapy
(5) adequate major organ
1)Lansky performance status;30<=
2)Hemoatologic fanction;WBC>= 2000/mm3
3)Hepatic fanction;ALT 300 IU/l <= and t-bil 2.0 mg/dl>=
4)Renal fanction; 5 years old > 0.8 mg/dl>=, 5-10 years old 1.2 mg/dl>=,
10-18 years 1.5 mg/dl>=,
5)cardiac fanction; unnessesary treatment
(6) written informed consent
Key exclusion criteria
(1)duplicate cancer
(2)history of pregnancy or lactation
(3) Patients complicated the mental disease or psychotic condition and were judged that can not participate in the study.
(4) Patients whose participation in the study is judged to be inappropriate by the attending doctor
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Iehara |
Organization
Kyoto Prefectural University of Medicine
Division name
Pediatrics
Zip code
Address
Kawaramachi-Hirokoji Kamigyo-ku, Kyoto 602-8566
TEL
075-251-5571
iehara@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Iehara |
Organization
Kyoto Prefectural University of Medicine
Division name
Pediatrics
Zip code
Address
Kawaramachi-Hirokoji Kamigyo-ku, Kyoto 602-8566
TEL
075-251-5571
Homepage URL
http://www.jnbsg.jp
iehara@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japan Neuroblastoma Study Group
Institute
Department
Personal name
Funding Source
Organization
A research grant from the Ministry of Health,
Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
japan
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
| 2010 | Year | 12 | Month | 09 | 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
| 2010 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 09 | Day |
Last modified on
| 2014 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005582
