Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
- Conditions
- Gastrointestinal Stromal TumorMetastatic Cancer
- Registration Number
- NCT00769782
- Lead Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Recurrence-free survival 7.5 years Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.
- Secondary Outcome Measures
Name Time Method Histological curative resection At surgery 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.
Types and severities of adverse events 7.5 years 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.
Overall survival 7.5 years Overall survival is defined as time from date of surgery until date of death from any cause.
Trial Locations
- Locations (37)
Aichi Cancer Center
🇯🇵Nagoya, Aichi, Japan
Aichi Medical University
🇯🇵Nagoya, Aichi, 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
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