UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003114 |
|---|---|
| Receipt number | R000003763 |
| Scientific Title | A phase II trial of neoadjuvant imatinib for large gastric GIST in Japan and Korea |
| Date of disclosure of the study information | 2010/01/28 |
| Last modified on | 2016/01/28 09:21:54 |
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Basic information
Public title
A phase II trial of neoadjuvant imatinib for large gastric GIST in Japan and Korea
Acronym
A phase II trial of neoadjuvant imatinib for large gastric GIST
Scientific Title
A phase II trial of neoadjuvant imatinib for large gastric GIST in Japan and Korea
Scientific Title:Acronym
A phase II trial of neoadjuvant imatinib for large gastric GIST
Region
| Japan | Asia(except Japan) |
Condition
Condition
Gastrointestinal Stromal Tumor (GIST)
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate efficacy and safety of imatinib which is used in neoadjuvant therapy for patients with GIST of the stomach origin with diameter of 10 cm or more.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Overall Survival (OS), Progression-free Survival (PFS), objective response rate, pathological response rate, rate of stomach preservation, treatment completion rate, incidence rate of adverse events, imatinib plasma level
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 | Maneuver |
Interventions/Control_1
Neoadjuvant imatinib (400 mg/day) for 6 months (24 weeks) + Gastrectomy + Adjuvant imatinib (400 mg/day) for 12 months (48 weeks)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who are histopathologically diagnosed as GIST
2)Patients with GIST of stomach origin
3)Patients with tumor diameter of 10 cm or more which is identified by abdominal CT
4)Patients who have neither apparent distant metastasis nor peritoneal metastasis
5)Patients with first onset of GIST
6)Patients who have not undergone any treatment including surgery, chemotherapy, and radiotherapy for the disease
7)Patients who take food orally
8)Patients who are at least 20 years old and less than 80 years old
9)Patients whose Performance Status (ECOG) is 0 or 1
10)Patients with the following organ function
11)Patients who submit written consent forms for the study participation
Key exclusion criteria
1)Patients who have a medical history of active double cancers in the past 5 years
2)Patients who have a medical history of GIST
3)Patients who have heart disease of NYHA (New York Heart Association) class III or IV
4)Patients who are pregnant, lactating, or with the intention of becoming pregnant (including men)
5)Patients who have uncontrollable diseases or serious complications
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukinori Kurokawa |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-E2, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-3251
ykurokawa@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukinori Kurokawa |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-E2, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-3251
Homepage URL
ykurokawa@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Japanese Study Group on GIST
Institute
Department
Personal name
Funding Source
Organization
Japanese Study Group on GIST
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
| 2010 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 01 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003763
