RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor. PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.
OBJECTIVES: * To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor. OUTLINE: This is a multicenter study. Patients undergo surgical resection of hepatic metastasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
All patients undergo suegery to achieve macroscopic complete resection within 28 days after enrollment (including enrollment day). As long as tumor free margin is ensured, all resection margin distances and all surgical procedure are accepted. Surgical treatment in this study excludes the following, radiofrequency ablation (RFA) without resection of liver only or microwave coagulation therapy (MCT) only; for RFA or MCT is used as additional treatment under judgment of primary physician for new liver tumor which comfirmed during surgery in different parts of liver except portion scheduled for resection, RFA and MCT are included. After histological curative resection, patients are observed without treatment until comfirming recurrence. Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally. For reccurrence is comfirmed, patients receive imatinib treatment, 400 mg/day orally.
Recurrence-free survival
Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.
Time frame: 7.5 years
Overall survival
Overall survival is defined as time from date of surgery until date of death from any cause.
Time frame: 7.5 years
Histological curative resection
Histological curative resection is defined as complete tumor removal which comfirmed by pathological assessment of resected tissue. For radiofrequency ablation (RFA) or microwave coagulation therapy (MCT) is used as additional treatment for the new liver tumor which confirmed during surgery in different parts of liver except the portion scheduled for resection, the case is regarded as incomplete resection (R1). For peritoneal metastasis is confirmed during surgery, the case is regarded as incomplete resection (R1) regardless of macroscopic complete resection.
Time frame: At surgery
Types and severities of adverse events
Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.
Time frame: 7.5 years
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Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Aichi Medical University
Nagoya, Aichi-ken, Japan
Hirosaki University, School of Medicine
Hirosaki, Aomori, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
International Goodwill Hospital
Yokohama, Kanagawa, Japan
Kochi Medical School
Nankoku, Kochi, Japan
Kyoto Second Red Cross Hospital
Kanigyou-ku, Kyoto, Japan
...and 27 more locations