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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003114
Receipt No. 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

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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
Email 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
Email ykurokawa@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Japanese Study Group on GIST
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003763

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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