Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
- Conditions
- Gastrointestinal Stromal TumorMetastatic Cancer
- Interventions
- Registration Number
- NCT00764595
- Lead Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.
- Detailed Description
OBJECTIVES:
* To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description imatinib mesylate imatinib mesylate All patients start imatinib mesylate as oral dose of 400 mg/d once daily after meal within 28 days after enrollment, and continue the treatment until 3 years after enrollment of the last patient.
- Primary Outcome Measures
Name Time Method Progression-free survival 7.5 years Progression-free survival is defined as time from date of starting protocol treatment until date of comfirmation of progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 or death from any cause, whichever comes first.
- Secondary Outcome Measures
Name Time Method Tumor response 48 weeks Tumor response is defined as best overall response by RECIST v1.0 from date of starting protocol treatment until 48 weeks after starting protocol treatment.
Overall survival 7.5 years Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.
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 (36)
Sakai Municipal Hospital
🇯🇵Sakai, Osaka, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Aichi Cancer Center
🇯🇵Nagoya, Aichi, Japan
Kyoto Second Red Cross Hospital
🇯🇵Kanigyou-ku, Kyoto, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
International Goodwill Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kochi Medical School
🇯🇵Nankoku, Kochi, Japan
Kimitsu Chuo Hospital
🇯🇵Kisarazu-city, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
Ryukyu University Hospital
🇯🇵Nishiharacho, Okinawa, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Aichi Medical University
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization Kure Medical Center
🇯🇵Kure, Hiroshima, Japan
Kawasaki Medical School
🇯🇵Kurashiki, Okayama, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Hirosaki University, School of Medicine
🇯🇵Hirosaki, Aomori, Japan
Niigata Prefectural Central Hospital
🇯🇵Joetsu, Niigata, Japan
Nagaoka Chuo General Hospital
🇯🇵Nagaoka, Niigata, Japan
Hamamatsu University School of Medicine
🇯🇵Hamamatsu, Shizuoka, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Tokyo Metropolitan - Komagome Hospital
🇯🇵Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
University of Miyazaki Hospital
🇯🇵Kiyotake, Miyazaki, Japan
Oita University Hospital
🇯🇵Yufu, Oita, Japan
Toyonaka Municipal Hospital
🇯🇵Toyonaka, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanashi, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Kagoshima University
🇯🇵Kagoshima, Japan
Kochi Health Sciences Center
🇯🇵Kochi, Japan
Juntendo University Shizuoka Hospital
🇯🇵Shizuoka, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Okayama University Hospital
🇯🇵Okayama, Japan