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

This study has been terminated.
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group Identifier:
First received: September 7, 2005
Last updated: February 2, 2009
Last verified: February 2009
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
Intervention Model: Parallel Assignment
Masking: None (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:

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.

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00149266

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
Study Chair: Mitsuru Sasako, MD Gastric Surgery Division, National Cancer Center Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00149266     History of Changes
Other Study ID Numbers: JCOG9502
Study First Received: September 7, 2005
Last Updated: February 2, 2009

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

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases processed this record on September 19, 2017