Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIIGATAU-TRIGIST0805 | Other Identifier | Niigata University Medical and Dental Hosptial |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Niigata University Medical & Dental Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| imatinib mesylate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib mesylate | Drug | Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Overall survival |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of gastrointestinal stromal tumor (GIST)
Hepatic metastasis meeting the following criteria:
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:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tatsuo Kanda, MD | Niigata University Medical & Dental Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Aichi Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.
| 7.5 years |
| 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 |
| Nagoya |
| Aichi-ken |
| 480-1195 |
| Japan |
| Hirosaki University, School of Medicine | Hirosaki | Aomori | 036-8562 | Japan |
| National Hospital Organization Kure Medical Center | Kure | Hiroshima | 737-0023 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-0815 | Japan |
| International Goodwill Hospital | Yokohama | Kanagawa | 245-0006 | Japan |
| Kochi Medical School | Nankoku | Kochi | 783-8505 | Japan |
| Kyoto Second Red Cross Hospital | Kanigyou-ku | Kyoto | 602-8026 | Japan |
| University of Miyazaki Hospital | Kiyotake | Miyazaki | 889-1692 | Japan |
| Niigata Prefectural Central Hospital | Jōetsu | Niigata | 943-0192 | Japan |
| Nagaoka Chuo General Hospital | Nagaoka | Niigata | 940-8653 | Japan |
| Oita University Hospital | Yufu | Oita Prefecture | 879-5593 | Japan |
| Kawasaki Medical School | Kurashiki | Okayama-ken | 701-01 | Japan |
| Ryukyu University Hospital | Nishiharacho | Okinawa | 903-0215 | Japan |
| Sakai Municipal Hospital | Sakai | Osaka | 590-0064 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Toyonaka Municipal Hospital | Toyonaka | Osaka | 560-8565 | Japan |
| Saitama Medical University International Medical Center | Hidaka | Saitama | 350-1241 | Japan |
| Hamamatsu University School of Medicine | Hamamatsu | Shizuoka | 431-3192 | Japan |
| University of Yamanashi Hospital | Chūō | Yamanashi | 409-3898 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Kagoshima University | Kagoshima | 890-8520 | Japan |
| Kimitsu Chuo Hospital | Kisarazu | 292-8535 | Japan |
| Kochi Health Sciences Center | Kochi | 781-8555 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Niigata University Medical and Dental Hospital | Niigata | 951-8510 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Juntendo University Shizuoka Hospital | Shizuoka | 410-2295 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| Tokushima University Hospital | Tokushima | 770-8503 | Japan |
| Tokyo Metropolitan - Komagome Hospital | Tokyo | 113-0021 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Toyama University Hospital | Toyama | 930-0194 | Japan |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided