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

NCT00769782 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000615624NIIGATAU-TRIGIST0804
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 37

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.

Conditions

Gastrointestinal Stromal Tumor; Metastatic Cancer

Keywords

gastrointestinal stromal tumor; liver metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  7.5 years

• Histological curative resection

  At surgery

• Types and severities of adverse events

  7.5 years

Study Arms (1)

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 Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally.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

Procedure: therapeutic conventional surgery

Interventions

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.

therapeutic conventional surgery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Niigata University Medical & Dental Hospital: collaborator

Study Sites (37)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

Aichi Medical University

Nagoya, Aichi-ken, 480-1195, Japan

Location

Hirosaki University, School of Medicine

Hirosaki, Aomori, 036-8562, Japan

Location

National Hospital Organization Kure Medical Center

Kure, Hiroshima, 737-0023, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-0815, Japan

Location

International Goodwill Hospital

Yokohama, Kanagawa, 245-0006, Japan

Location

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

Location

Kyoto Second Red Cross Hospital

Kanigyou-ku, Kyoto, 602-8026, Japan

Location

University of Miyazaki Hospital

Kiyotake, Miyazaki, 889-1692, Japan

Location

Niigata Prefectural Central Hospital

Jōetsu, Niigata, 943-0192, Japan

Location

Nagaoka Chuo General Hospital

Nagaoka, Niigata, 940-8653, Japan

Location

Kawasaki Medical School

Kurashiki, Okayama-ken, 701-01, Japan

Location

Ryukyu University Hospital

Nishiharacho, Okinawa, 903-0215, Japan

Location

Sakai Municipal Hospital

Sakai, Osaka, 590-0064, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Toyonaka Municipal Hospital

Toyonaka, Osaka, 560-8565, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1241, Japan

Location

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

University of Yamanashi Hospital

Chūō, Yamanashi, 409-3898, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Kagoshima University

Kagoshima, 890-8520, Japan

Location

Kimitsu Chuo Hospital

Kisarazu, 292-8535, Japan

Location

Kochi Health Sciences Center

Kochi, 781-8555, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, 951-8510, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Juntendo University Shizuoka Hospital

Shizuoka, 410-2295, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Tokyo Metropolitan - Komagome Hospital

Tokyo, 113-0021, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tatsuo Kanda, MD

  Niigata University Medical & Dental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

JP (37)