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Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00149266
First received: September 7, 2005
Last updated: February 2, 2009
Last verified: February 2009
History of Changes
  Purpose

To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer


Condition Intervention Phase
Gastric Neoplasm
 Procedure: Surgery: abdominal and transhiatal approach
Procedure: Surgery: left thoraco-abdominal approach
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • relapse-free survival
  • operative morbidity and mortality
  • quality of life

Enrollment: 167
Study Start Date: July 1995
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histologically proven adenocarcinoma
  2. 75 years old or younger
  3. forced expiratory volume in one second ≥ 50 %
  4. arterial oxygen pressure in room air ≥ 70 mmHg
  5. clinically T2/T3/T4 with ≤3 cm esophageal invasion
  6. written consent

Exclusion Criteria:

  1. Carcinoma in the remnant stomach
  2. Borrmann type 4 (linitis plastica)
  3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
  4. history of left thoracotomy, or left pleural adhesion
  5. past history of myocardial infarction or positive results of exercise ECG
  6. liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149266

Locations
Japan
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Mitsuru Sasako, MD Gastric Surgery Division, National Cancer Center Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00149266     History of Changes
Other Study ID Numbers: JCOG9502, C000000122
Study First Received: September 7, 2005
Last Updated: February 2, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
stomach neoplasms
lymph node resection
cardia
thoracotomy

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 19, 2013