Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Multicenter Clinical Trial on Surgery for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)

Conditions
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Gastrointestinal Stromal Tumor, Metastatic Cancer

Intervention / Treatment
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* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: therapeutic conventional surgery<br>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. | Procedure: therapeutic conventional surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastases, gastrointestinal stromal tumor