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 III

Further Study Details: 

Primary Outcomes: overall survival
Secondary Outcomes: relapse-free survival; operative morbidity and mortality; quality of life
Expected Total Enrollment:  265

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,  Genders Eligible for Study:  Both

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%

Japan, Tokyo
      National Cancer Center Hospital, 5-1-1,Tsukiji,Chuo-ku,  Tokyo,  104-0045,  Japan

Study chairs or principal investigators

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

Study ID Numbers:  JCOG9502; C000000122
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00149266
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13