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

UMIN ID: UMIN000000950

Registered date:17/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastrointestinal stromal tumor (GIST)
• Date of first enrollment: 2007/12/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Imanitib 400 mg/day for 1 year
Imanitib 400 mg/day for 6 months

Outcome(s)

• Primary Outcome: Recurrence-free survival
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Kinki GIST Study Group
• Source(s) of Monetary Support: Kinki GIST Study Group