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

NCT ID: NCT00769782

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2016-03-31

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 liver metastasis from a gastrointestinal stromal tumor.

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.

Patients undergo surgical resection of hepatic metastasis.

Conditions

Gastrointestinal Stromal Tumor; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

therapeutic conventional surgery

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 Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally.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.

Group Type: EXPERIMENTAL

therapeutic conventional surgery

Intervention Type: 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.

Interventions

therapeutic conventional surgery

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Niigata University Medical & Dental Hospital

OTHER

Sponsor Role: collaborator

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatsuo Kanda, MD

Role: PRINCIPAL_INVESTIGATOR

Niigata University Medical & Dental Hospital

Locations

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Aichi Medical University

Nagoya, Aichi-ken, Japan

Hirosaki University, School of Medicine

Hirosaki, Aomori, Japan

National Hospital Organization Kure Medical Center

Kure, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

International Goodwill Hospital

Yokohama, Kanagawa, Japan

Kochi Medical School

Nankoku, Kochi, Japan

Kyoto Second Red Cross Hospital

Kanigyou-ku, Kyoto, Japan

University of Miyazaki Hospital

Kiyotake, Miyazaki, Japan

Niigata Prefectural Central Hospital

Jōetsu, Niigata, Japan

Nagaoka Chuo General Hospital

Nagaoka, Niigata, Japan

Kawasaki Medical School

Kurashiki, Okayama-ken, Japan

Ryukyu University Hospital

Nishiharacho, Okinawa, Japan

Sakai Municipal Hospital

Sakai, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Toyonaka Municipal Hospital

Toyonaka, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

Kyushu University Hospital

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Kagoshima University

Kagoshima, , Japan

Kimitsu Chuo Hospital

Kisarazu, , Japan

Kochi Health Sciences Center

Kochi, , Japan

Kumamoto University Hospital

Kumamoto, , Japan

Niigata University Medical and Dental Hospital

Niigata, , Japan

Niigata Cancer Center Hospital

Niigata, , Japan

Okayama University Hospital

Okayama, , Japan

Juntendo University Shizuoka Hospital

Shizuoka, , Japan

Shizuoka Cancer Center

Shizuoka, , Japan

Tokushima University Hospital

Tokushima, , Japan

Tokyo Metropolitan - Komagome Hospital

Tokyo, , Japan

Keio University Hospital

Tokyo, , Japan

Toyama University Hospital

Toyama, , Japan

Yamagata University Hospital

Yamagata, , Japan

Countries

Japan

Other Identifiers

NIIGATAU-TRIGIST0804

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000615624

Identifier Type: -

Identifier Source: org_study_id