Metastatic Cancer Clinical Trial
— GISTsOfficial title:
Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
Verified date | July 2023 |
Source | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | DISEASE CHARACTERISTICS: - Diagnosis of gastrointestinal stromal tumor (GIST) - Hepatic metastasis meeting the following criteria: - No more than 3 hepatic metastases - Clinically diagnosed as surgically resectable with no macroscopic residual tumor - Synchronous hepatic metastasis allowed provided primary tumor is also resectable - No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease - No extrahepatic metastasis - No history of GIST recurrence PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Leukocyte count = 3,000/µL - Neutrophil count = 1,500/µL - Hemoglobin = 8.0 g/dL - Platelet count = 75,000/µL - Total bilirubin = 2.0 mg/dL - ALT and AST < 120 IU/L - GTP < 210 IU/L - Not pregnant - No poorly controlled diabetes mellitus - No NYHA class III-IV cardiac function - No hepatitis B or hepatitis B carriers - No other malignancy requiring treatment PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior imatinib mesylate - No prior interventional radiology for metastatic disease - No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions |
Country | Name | City | State |
---|---|---|---|
Japan | University of Yamanashi Hospital | Chuo | Yamanashi |
Japan | Kyushu University Hospital | Fukuoka | |
Japan | Fukushima Medical University Hospital | Fukushima | |
Japan | Hamamatsu University School of Medicine | Hamamatsu | Shizuoka |
Japan | Saitama Medical University International Medical Center | Hidaka | Saitama |
Japan | Hirosaki University, School of Medicine | Hirosaki | Aomori |
Japan | Niigata Prefectural Central Hospital | Joetsu | Niigata |
Japan | Kagoshima University | Kagoshima | |
Japan | Kyoto Second Red Cross Hospital | Kanigyou-ku | Kyoto |
Japan | Kimitsu Chuo Hospital | Kisarazu-city | |
Japan | University of Miyazaki Hospital | Kiyotake | Miyazaki |
Japan | Kochi Health Sciences Center | Kochi | |
Japan | Kumamoto University Hospital | Kumamoto | |
Japan | Kawasaki Medical School | Kurashiki | Okayama |
Japan | National Hospital Organization Kure Medical Center | Kure | Hiroshima |
Japan | Nagaoka Chuo General Hospital | Nagaoka | Niigata |
Japan | Aichi Cancer Center | Nagoya | Aichi |
Japan | Aichi Medical University | Nagoya | Aichi |
Japan | Kochi Medical School | Nankoku | Kochi |
Japan | Niigata Cancer Center Hospital | Niigata | |
Japan | Niigata University Medical and Dental Hospital | Niigata | |
Japan | Ryukyu University Hospital | Nishiharacho | Okinawa |
Japan | Okayama University Hospital | Okayama | |
Japan | Sakai Municipal Hospital | Sakai | Osaka |
Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
Japan | Juntendo University Shizuoka Hospital | Shizuoka | |
Japan | Shizuoka Cancer Center | Shizuoka | |
Japan | Osaka University Hospital | Suita | Osaka |
Japan | Tokushima University Hospital | Tokushima | |
Japan | Keio University Hospital | Tokyo | |
Japan | Tokyo Metropolitan - Komagome Hospital | Tokyo | |
Japan | Toyama University Hospital | Toyama | |
Japan | Toyonaka Municipal Hospital | Toyonaka | Osaka |
Japan | International Goodwill Hospital | Yokohama | Kanagawa |
Japan | Kanagawa Cancer Center | Yokohama | Kanagawa |
Japan | Oita University Hospital | Yufu | Oita |
Lead Sponsor | Collaborator |
---|---|
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Niigata University Medical & Dental Hospital |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | 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. | 7.5 years | |
Secondary | Tumor response | 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. | 48 weeks | |
Secondary | Overall survival | Overall survival is defined as time from date of starting protocol treatment until date of death from any cause. | 7.5 years | |
Secondary | 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. | 7.5 years |
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