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

Primary Purpose

Gastrointestinal Stromal Tumor, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
therapeutic conventional surgery
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor focused on measuring gastrointestinal stromal tumor, liver metastases

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center
  • Aichi Medical University
  • Hirosaki University, School of Medicine
  • National Hospital Organization Kure Medical Center
  • Hokkaido University Hospital
  • Iwate Medical University Hospital
  • Kanagawa Cancer Center
  • International Goodwill Hospital
  • Kochi Medical School
  • Kyoto Second Red Cross Hospital
  • University of Miyazaki Hospital
  • Niigata Prefectural Central Hospital
  • Nagaoka Chuo General Hospital
  • Kawasaki Medical School
  • Ryukyu University Hospital
  • Sakai Municipal Hospital
  • Osaka University Hospital
  • Toyonaka Municipal Hospital
  • Saitama Medical University International Medical Center
  • Hamamatsu University School of Medicine
  • University of Yamanashi Hospital
  • Kyushu University Hospital
  • Fukushima Medical University Hospital
  • Kagoshima University
  • Kimitsu Chuo Hospital
  • Kochi Health Sciences Center
  • Kumamoto University Hospital
  • Niigata University Medical and Dental Hospital
  • Niigata Cancer Center Hospital
  • Okayama University Hospital
  • Juntendo University Shizuoka Hospital
  • Shizuoka Cancer Center
  • Tokushima University Hospital
  • Tokyo Metropolitan - Komagome Hospital
  • Keio University Hospital
  • Toyama University Hospital
  • Yamagata University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

therapeutic conventional surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival
Overall survival is defined as time from date of surgery until date of death from any cause.
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.
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.

Full Information

First Posted
October 8, 2008
Last Updated
July 19, 2023
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Niigata University Medical & Dental Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00769782
Brief Title
Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Acronym
GISTs
Official Title
Phase II Multicenter Clinical Trial on Surgery for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Niigata University Medical & Dental Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor, Metastatic Cancer
Keywords
gastrointestinal stromal tumor, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
therapeutic conventional surgery
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.
Time Frame
7.5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is defined as time from date of surgery until date of death from any cause.
Time Frame
7.5 years
Title
Histological curative resection
Description
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.
Time Frame
At surgery
Title
Types and severities of adverse events
Description
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.
Time Frame
7.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuo Kanda, MD
Organizational Affiliation
Niigata University Medical & Dental Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Aichi Medical University
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Hirosaki University, School of Medicine
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8562
Country
Japan
Facility Name
National Hospital Organization Kure Medical Center
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
International Goodwill Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-0006
Country
Japan
Facility Name
Kochi Medical School
City
Nankoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Facility Name
Kyoto Second Red Cross Hospital
City
Kanigyou-ku
State/Province
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Kiyotake
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Niigata Prefectural Central Hospital
City
Joetsu
State/Province
Niigata
ZIP/Postal Code
943-0192
Country
Japan
Facility Name
Nagaoka Chuo General Hospital
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-8653
Country
Japan
Facility Name
Kawasaki Medical School
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-01
Country
Japan
Facility Name
Ryukyu University Hospital
City
Nishiharacho
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Sakai Municipal Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0064
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Toyonaka Municipal Hospital
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-8565
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1241
Country
Japan
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
University of Yamanashi Hospital
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Kagoshima University
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kimitsu Chuo Hospital
City
Kisarazu-city
ZIP/Postal Code
292-8535
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
ZIP/Postal Code
951-8510
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Shizuoka
ZIP/Postal Code
410-2295
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Tokyo Metropolitan - Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-0021
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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