Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
- Conditions
- Gastrointestinal Stromal TumorMetastatic Cancer
- Interventions
- Procedure: therapeutic conventional surgery
- 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
- Arm && Interventions
Group Intervention Description therapeutic conventional surgery therapeutic conventional surgery 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 Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally.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.
- 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 Overall survival 7.5 years Overall survival is defined as time from date of surgery until date of death from any cause.
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.
Trial Locations
- Locations (37)
Ryukyu University Hospital
🇯🇵Nishiharacho, Okinawa, Japan
Toyonaka Municipal Hospital
🇯🇵Toyonaka, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Aichi Cancer Center
🇯🇵Nagoya, Aichi, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hirosaki University, School of Medicine
🇯🇵Hirosaki, Aomori, Japan
Aichi Medical University
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization Kure Medical Center
🇯🇵Kure, Hiroshima, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
International Goodwill Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kochi Medical School
🇯🇵Nankoku, Kochi, Japan
University of Miyazaki Hospital
🇯🇵Kiyotake, Miyazaki, Japan
Kyoto Second Red Cross Hospital
🇯🇵Kanigyou-ku, Kyoto, Japan
Niigata Prefectural Central Hospital
🇯🇵Joetsu, Niigata, Japan
Nagaoka Chuo General Hospital
🇯🇵Nagaoka, Niigata, Japan
Kawasaki Medical School
🇯🇵Kurashiki, Okayama, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Sakai Municipal Hospital
🇯🇵Sakai, Osaka, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanashi, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Hamamatsu University School of Medicine
🇯🇵Hamamatsu, Shizuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Kagoshima University
🇯🇵Kagoshima, Japan
Kimitsu Chuo Hospital
🇯🇵Kisarazu-city, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
Kochi Health Sciences Center
🇯🇵Kochi, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Juntendo University Shizuoka Hospital
🇯🇵Shizuoka, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Tokyo Metropolitan - Komagome Hospital
🇯🇵Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan