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Completed

NCT Number: NCT00769782

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

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.

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Key information

Conditions

Gastrointestinal Stromal Tumor Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic conventional surgery

Procedure

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 outcomes

  1. Recurrence-free survival

    Time frame: 7.5 years

    Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.

Secondary outcomes

  1. Overall survival

    Time frame: 7.5 years

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

  2. Histological curative resection

    Time frame: At surgery

    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.

  3. Types and severities of adverse events

    Time frame: 7.5 years

    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.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Niigata University Medical & Dental Hospital

Registry information

Official study title

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

Acronym: GISTs

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2008
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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