Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIIGATAU-TRIGIST0804 | Other Identifier | Niigata University Medical and Dental Hospital |
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: 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.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo surgical resection of hepatic metastasis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapeutic conventional surgery | Experimental | 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 Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally.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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first. | 7.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is defined as time from date of surgery until date of death from any cause. | 7.5 years |
| Histological curative resection | 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. |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of gastrointestinal stromal tumor (GIST)
Hepatic metastasis meeting the following criteria:
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
|
| At surgery |
| 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 |
| Iwate Medical University Hospital | Morioka | Iwate | 020-8505 | 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 |
| 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 |
| Yamagata University Hospital | Yamagata | 990-9585 | 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