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

Metastatic Cancer Clinical Trial

— GISTs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769782
• Other study ID #: CDR0000615624
• Secondary ID: NIIGATAU-TRIGIST
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: March 2016

Study information

• Verified date: July 2023
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Japan	University of Yamanashi Hospital	Chuo	Yamanashi
Japan	Kyushu University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hirosaki University, School of Medicine	Hirosaki	Aomori
Japan	Niigata Prefectural Central Hospital	Joetsu	Niigata
Japan	Kagoshima University	Kagoshima
Japan	Kyoto Second Red Cross Hospital	Kanigyou-ku	Kyoto
Japan	Kimitsu Chuo Hospital	Kisarazu-city
Japan	University of Miyazaki Hospital	Kiyotake	Miyazaki
Japan	Kochi Health Sciences Center	Kochi
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kawasaki Medical School	Kurashiki	Okayama
Japan	National Hospital Organization Kure Medical Center	Kure	Hiroshima
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Nagaoka Chuo General Hospital	Nagaoka	Niigata
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Aichi Medical University	Nagoya	Aichi
Japan	Kochi Medical School	Nankoku	Kochi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Ryukyu University Hospital	Nishiharacho	Okinawa
Japan	Okayama University Hospital	Okayama
Japan	Sakai Municipal Hospital	Sakai	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Juntendo University Shizuoka Hospital	Shizuoka
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Osaka University Hospital	Suita	Osaka
Japan	Tokushima University Hospital	Tokushima
Japan	Keio University Hospital	Tokyo
Japan	Tokyo Metropolitan - Komagome Hospital	Tokyo
Japan	Toyama University Hospital	Toyama
Japan	Toyonaka Municipal Hospital	Toyonaka	Osaka
Japan	Yamagata University Hospital	Yamagata
Japan	International Goodwill Hospital	Yokohama	Kanagawa
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Niigata University Medical & Dental Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	Overall survival is defined as time from date of surgery until date of death from any cause.	7.5 years
Secondary	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
Secondary	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