Status:
COMPLETED
Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Niigata University Medical & Dental Hospital
Conditions:
Gastrointestinal Stromal Tumor
Metastatic Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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. Patien...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00769782
Start Date
October 1 2008
End Date
March 1 2016
Last Update
July 21 2023
Active Locations (37)
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1
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
2
Aichi Medical University
Nagoya, Aichi-ken, Japan, 480-1195
3
Hirosaki University, School of Medicine
Hirosaki, Aomori, Japan, 036-8562
4
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan, 737-0023