NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000950

Registered date:17/12/2007

A randomized phase II trial of postoperative adjuvant therapy with imanitib for 1 Year versus 6 months in patients with gastrointestinal stromal tumors

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedGastrointestinal stromal tumor (GIST)
Date of first enrollment2007/12/01
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Imanitib 400 mg/day for 1 year Imanitib 400 mg/day for 6 months

Outcome(s)

Primary OutcomeRecurrence-free survival
Secondary OutcomeOverall 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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Related Information

Contact

public contact
Name Yukinori Kurokawa
Address 2-2-E2, Yamadaoka, Suita-shi, Osaka Japan
Telephone 06-6879-3251
E-mail ykurokawa@gesurg.med.osaka-u.ac.jp
Affiliation Osaka University Department of Gastroenterological Surgery
scientific contact
Name Toshimasa Tsujinaka
Address 2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan Japan
Telephone 06-6942-1331
E-mail tsujinaka@hosp.kaizuka.osaka.jp
Affiliation Osaka National Hospital Department of Surgery