Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
This study is ongoing, but not recruiting participants.
Sponsor:
Niigata University Medical and Dental Hospital
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00769782
First received: October 8, 2008
Last updated: August 31, 2011
Last verified: July 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor Metastatic Cancer |
Procedure: therapeutic conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Multicenter Clinical Trial on Surgery for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs) |
Resource links provided by NLM:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Recurrence-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Microscopically complete resection rate (R0 resection) [ Designated as safety issue: No ]
- Postoperative morbidity and mortality [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of gastrointestinal stromal tumor (GIST)
Hepatic metastasis meeting the following criteria:
- Clinically diagnosed as surgically resectable with no macroscopic residual tumor
- No more than 3 hepatic metastases
- Synchronous hepatic metastasis allowed provided primary tumor is also resectable
- Does not require 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 interventional radiology for metastatic disease
- No prior or concurrent imatinib mesylate
- No other concurrent treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769782
Locations
| Japan | |
| Aichi Medical University | |
| Nagoya, Aichi, Japan, 480-1195 | |
| Aichi Cancer Center | |
| Nagoya, Aichi, Japan, 464-8681 | |
| Hirosaki University, School of Medicine | |
| Hirosaki, Aomori, Japan, 036-8562 | |
| National Hospital Organization Kure Medical Center | |
| Kure, Hiroshima, Japan, 737-0023 | |
| Hokkaido University Hospital | |
| Sapporo, Hokkaido, Japan, 060-8648 | |
| Iwate Medical University Hospital | |
| Morioka, Iwate, Japan, 020-8505 | |
| Kanagawa Cancer Center | |
| Yokohama, Kanagawa, Japan, 241-0815 | |
| International Goodwill Hospital | |
| Yokohama, Kanagawa, Japan, 245-0006 | |
| Kochi Medical School | |
| Nankoku, Kochi, Japan, 783-8505 | |
| Kyoto Second Red Cross Hospital | |
| Kanigyou-ku, Kyoto, Japan, 602-8026 | |
| University of Miyazaki Hospital | |
| Kiyotake, Miyazaki, Japan, 889-1692 | |
| Niigata Prefectural Central Hospital | |
| Joetsu, Niigata, Japan, 943-0192 | |
| Nagaoka Chuo General Hospital | |
| Nagaoka, Niigata, Japan, 940-8653 | |
| Kawasaki Medical School | |
| Kurashiki, Okayama, Japan, 701-01 | |
| Ryukyu University Hospital | |
| Nishiharacho, Okinawa, Japan, 903-0215 | |
| Sakai Municipal Hospital | |
| Sakai, Osaka, Japan, 590-0064 | |
| Osaka University Hospital | |
| Suita, Osaka, Japan, 565-0871 | |
| Toyonaka Municipal Hospital | |
| Toyonaka, Osaka, Japan, 560-8565 | |
| Saitama Medical University International Medical Center | |
| Hidaka, Saitama, Japan, 350-1241 | |
| Hamamatsu University School of Medicine | |
| Hamamatsu, Shizuoka, Japan, 431-3192 | |
| University of Yamanashi Hospital | |
| Chuo, Yamanashi, Japan, 409-3898 | |
| Kyushu University Hospital | |
| Fukuoka, Japan, 812-8582 | |
| Fukushima Medical University Hospital | |
| Fukushima, Japan, 960-1295 | |
| Kagoshima University | |
| Kagoshima, Japan, 890-8520 | |
| Kimitsu Chuo Hospital | |
| Kisarazu-city, Japan, 292-8535 | |
| Kochi Health Sciences Center | |
| Kochi, Japan, 781-8555 | |
| Kumamoto University Hospital | |
| Kumamoto, Japan, 860-8556 | |
| Niigata University Medical and Dental Hospital | |
| Niigata, Japan, 951-8510 | |
| Niigata Cancer Center Hospital | |
| Niigata, Japan, 951-8566 | |
| Okayama University Hospital | |
| Okayama, Japan, 700-8558 | |
| Shizuoka Cancer Center | |
| Shizuoka, Japan, 411-8777 | |
| Juntendo University Shizuoka Hospital | |
| Shizuoka, Japan, 410-2295 | |
| Tokushima University Hospital | |
| Tokushima, Japan, 770-8503 | |
| Tokyo Metropolitan - Komagome Hospital | |
| Tokyo, Japan, 113-0021 | |
| Keio University Hospital | |
| Tokyo, Japan, 160-8582 | |
| Toyama University Hospital | |
| Toyama, Japan, 930-0194 | |
| Yamagata University Hospital | |
| Yamagata, Japan, 990-9585 | |
Sponsors and Collaborators
Niigata University Medical and Dental Hospital
Investigators
| Principal Investigator: | Tatsuo Kanda, MD | Niigata University Medical and Dental Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00769782 History of Changes |
| Other Study ID Numbers: | CDR0000615624, NIIGATAU-TRIGIST0804 |
| Study First Received: | October 8, 2008 |
| Last Updated: | August 31, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
gastrointestinal stromal tumor liver metastases |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Gastrointestinal Stromal Tumors Neoplastic Processes Pathologic Processes |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013