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

This study has been completed.
Sponsor:
Collaborator:
Niigata University Medical & Dental Hospital
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00769782
First received: October 8, 2008
Last updated: September 27, 2016
Last verified: September 2016
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Recurrence-free survival [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]
    Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as time from date of surgery until date of death from any cause.

  • Histological curative resection [ Time Frame: At surgery ] [ Designated as safety issue: No ]
    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.

  • Types and severities of adverse events [ Time Frame: 7.5 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 6
Study Start Date: October 2008
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769782

Locations
Japan
Aichi Cancer Center
Nagoya, Aichi, Japan, 464-8681
Aichi Medical University
Nagoya, Aichi, Japan, 480-1195
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
Juntendo University Shizuoka Hospital
Shizuoka, Japan, 410-2295
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
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
Translational Research Informatics Center, Kobe, Hyogo, Japan
Niigata University Medical & Dental Hospital
Investigators
Principal Investigator: Tatsuo Kanda, MD Niigata University Medical & Dental Hospital
  More Information

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00769782     History of Changes
Other Study ID Numbers: CDR0000615624  NIIGATAU-TRIGIST0804 
Study First Received: October 8, 2008
Last Updated: September 27, 2016
Health Authority: Japan: Translational Research Informatics Center Ethical Committiee

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
gastrointestinal stromal tumor
liver metastases

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on December 02, 2016