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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

September 7, 2005
February 2, 2009
July 1995
December 2008   (final data collection date for primary outcome measure)
overall survival
Same as current
Complete list of historical versions of study NCT00149266 on ClinicalTrials.gov Archive Site
  • relapse-free survival
  • operative morbidity and mortality
  • quality of life
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Neoplasm
  • Procedure: Surgery: abdominal and transhiatal approach
  • Procedure: Surgery: left thoraco-abdominal approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
167
December 2008
December 2008   (final data collection date for primary outcome measure)

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%
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00149266
JCOG9502, C000000122
Yes
Not Provided
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Mitsuru Sasako, MD Gastric Surgery Division, National Cancer Center Hospital
Japan Clinical Oncology Group
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP