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

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ClinicalTrials.gov Identifier: NCT00149266
Recruitment Status : Terminated
First Posted : September 8, 2005
Last Update Posted : February 3, 2009
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
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)
Study Start Date : July 1995
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. relapse-free survival
  2. operative morbidity and mortality
  3. quality of life


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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
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
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009

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

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