UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004989 |
|---|---|
| Receipt number | R000005882 |
| Scientific Title | Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST) |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2014/08/01 10:25:20 |
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Basic information
Public title
Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST)
Acronym
Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST)
Scientific Title
Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST)
Scientific Title:Acronym
Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST)
Region
| Japan |
Condition
Condition
Gastrointestinal Stromal Tumor (GIST)
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the efficacy of Imatinib treatment in the adjuvant setting on patients with GIST
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence-Free Survival (RFS)
Key secondary outcomes
1.Accomplishment rate of treatment
2.Overall survival (OS)
3.To examine factors for Imatinib treatment continuation
4.Relationship between mutation and survival term (RFS, OS)
5.Occurrence rate of adverse events
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
Prevention
Type of intervention
| Medicine | Gene |
Interventions/Control_1
To examine gene-mutation of resected tumor cell
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients pathologically diagnosed as GIST
2.Patients with KIT positive by immunohistological study
3.Patients who were macroscopically 4.Intermediate or High risk (including clinically malignant) classified by Fletcher category
5.Age: ≥>=20 & <75
6.Patients who have no previous treatment 7.Patients who could start adjuvant treatment within 2-12 weeks
8.PS(ECOG):0-2
9.Patients who To be able to take orally
10.Patients who Maintain major organ function (2 weeks after surgery & 30 days before submission)
11.Patients who acquire agreement by written document
Key exclusion criteria
1.Patients who have a medical history of active double cancers without cis in the past 5 years
2.Patients who have active infectious disease by bacteria and/or fungus
3.Patients who have heart disease of NYHA class III or IV
4.Patients who are pregnant, lactating, or with the intention of becoming pregnant (including men)
5.Patients who have mental disorder and considered inappropriate for registration to this study
6.Patients who were judged to be unacceptable for enrollment by investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hanasaki |
Organization
Kochi Medical University
Division name
Department of Surgery
Zip code
Address
Kohasu-Okocho, Nankoku-City, Kochi 783-8505, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kochi Medical University
Division name
Department of Surgery
Zip code
Address
Kohasu-Okocho, Nankoku-City, Kochi 783-8505, Japan.
TEL
Homepage URL
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical University Department of Surgery
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 01 | Day |
Last modified on
| 2014 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005882
