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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer; Gastrointestinal Stromal Tumor
• Intervention / Treatment: Procedure: therapeutic conventional surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Kagoshima, Japan, 890-8520
    • Kagoshima University
  • Kisarazu-city, Japan, 292-8535
    • Kimitsu Chuo Hospital
  • Kochi, Japan, 781-8555
    • Kochi Health Sciences Center
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Niigata, Japan, 951-8510
    • Niigata University Medical And Dental Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Shizuoka, Japan, 410-2295
    • Juntendo University Shizuoka Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Tokyo, Japan, 113-0021
    • Tokyo Metropolitan - Komagome Hospital
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center
    • Nagoya, Aichi, Japan, 480-1195
      • Aichi Medical University
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8562
      • Hirosaki University, School of Medicine
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-0023
      • National Hospital Organization Kure Medical Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Iwate Medical University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-0815
      • Kanagawa Cancer Center
    • Yokohama, Kanagawa, Japan, 245-0006
      • International Goodwill Hospital
  • Kochi
    • Nankoku, Kochi, Japan, 783-8505
      • Kochi Medical School
  • Kyoto
    • Kanigyou-ku, Kyoto, Japan, 602-8026
      • Kyoto Second Red Cross Hospital
  • Miyazaki
    • Kiyotake, Miyazaki, Japan, 889-1692
      • University of Miyazaki Hospital
  • Niigata
    • Joetsu, Niigata, Japan, 943-0192
      • Niigata Prefectural Central Hospital
    • Nagaoka, Niigata, Japan, 940-8653
      • Nagaoka Chuo General Hospital
  • Okayama
    • Kurashiki, Okayama, Japan, 701-01
      • Kawasaki Medical School
  • Okinawa
    • Nishiharacho, Okinawa, Japan, 903-0215
      • Ryukyu University Hospital
  • Osaka
    • Sakai, Osaka, Japan, 590-0064
      • Sakai Municipal Hospital
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
    • Toyonaka, Osaka, Japan, 560-8565
      • Toyonaka Municipal Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1241
      • Saitama Medical University International Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University School of Medicine
  • Yamanashi
    • Chuo, Yamanashi, Japan, 409-3898
      • University of Yamanashi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Niigata University Medical & Dental Hospital
• Investigators: Principal Investigator: Tatsuo Kanda, MD, Niigata University Medical & Dental Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 8, 2008
• First Submitted That Met QC Criteria: October 8, 2008
• First Posted (Estimated): October 9, 2008

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: liver metastases; gastrointestinal stromal tumor
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplastic Processes; Neoplasms, Connective Tissue; Neoplasm Metastasis; Gastrointestinal Stromal Tumors
• Other Study ID Numbers: CDR0000615624; NIIGATAU-TRIGIST0804 (Other Identifier: Niigata University Medical and Dental Hospital)