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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00769782
Other study ID # CDR0000615624
Secondary ID NIIGATAU-TRIGIST
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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