Status:

TERMINATED

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

Lead Sponsor:

Japan Clinical Oncology Group

Collaborating Sponsors:

Ministry of Health, Labour and Welfare, Japan

Conditions:

Gastric Neoplasm

Eligibility:

All Genders

Up to 75 years

Phase:

PHASE3

Brief Summary

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

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, patient...

Eligibility Criteria

Inclusion

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

Exclusion

  • Carcinoma in the remnant stomach
  • Borrmann type 4 (linitis plastica)
  • synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
  • history of left thoracotomy, or left pleural adhesion
  • past history of myocardial infarction or positive results of exercise ECG
  • liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%

Key Trial Info

Start Date :

July 1 1995

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

167 Patients enrolled

Trial Details

Trial ID

NCT00149266

Start Date

July 1 1995

End Date

December 1 2008

Last Update

February 3 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045