UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized phase II trial of postoperative adjuvant therapy with imanitib for 1 Year versus 6 months in patients with gastrointestinal stromal tumors
Title of the study (Brief title)	Randomized trial of adjuvant therapy with imanitib for 1 year versus 6 months in GIST patients
Region	Japan

Condition
Condition	Gastrointestinal stromal tumor (GIST)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparative efficacy and safety of 1-year versus 6-month adjuvant therapy with imanitib in GIST patients who underwent curative resection for new-onset disease and who were judged as being at intermediate or high risk (including clinical malignant) of recurrence according to risk stratification criteria
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence-free survival
Key secondary outcomes	Overall survival; treatment completion rate; the relationship of mutations of c-kit and PDGFRA as well as mRNA expression of their related factors to survival period (recurrence-free survival and overall survival); and adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Imanitib 400 mg/day for 1 year
Interventions/Control_2	Imanitib 400 mg/day for 6 months
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) A confirmed diagnosis of GIST by immunohistochemical test using resected sample or gene mutation test 2) Judgement as being at intermediate or high risk (including clinical malignant) according to risk stratification criteria 3) New-onset lesions (regardless of their primary sites) 4) Macroscopic curative resection (R0 or R1) has been carried out. 5) Judgement as being able to receive imanitib therapy within 12 weeks after surgery 6) Adequate organ function defined as indicated by the following blood test findings obtained within 4 weeks before enrollment Neutrophils count: >=1,500/mm3 Platelet count: >=100,000/mm3 Total bilirubin: <=1.5 times the upper limit of normal (ULN) AST(sGOT): <=2.5 times the ULN ALT(sGPT): <=2.5 times the ULN Creatinine: <=1.5 times the ULN 7) An ECOG performance status of 0 or 1 8) Age 20 to <80 years old 9) Written informed consent by the patient to participation in the study
Key exclusion criteria	1) Familial GIST or GIST complicated with von Recklinghausen disease (NF type 1) 2) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years). Carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) that are judged as having been cured by local treatment is not included in active double cancer. 3) Prior chemotherapy, radiotherapy, or immunotherapy after resection of lesions 4) Prior treatment with imanitib 5) Cardiac disease assigned to NYHA class III or IV 6) Women who are pregnant, breast-feeding, or planning to become pregnant 7) Active mycosis and other infections 8) Other conditions judged as inappropriate for the study by the investigator
Target sample size	80

Research contact person
Name of lead principal investigator	Toshimasa Tsujinaka
Organization	Osaka National Hospital
Division name	Department of Surgery
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan
TEL	06-6942-1331
Email	tsujinaka@hosp.kaizuka.osaka.jp

Public contact
Name of contact person	Yukinori Kurokawa
Organization	Osaka University
Division name	Department of Gastroenterological Surgery
Address	2-2-E2, Yamadaoka, Suita-shi, Osaka
TEL	06-6879-3251
Homepage URL
Email	ykurokawa@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Kinki GIST Study Group
Institute
Department

Funding Source
Organization	Kinki GIST Study Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2007 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 11 Month 07 Day
Anticipated trial start date	2007 Year 12 Month 01 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 12 Month 15 Day
Last modified on	2018 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001140