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

Phase 3TerminatedNCT00149266

Japan Clinical Oncology Group167 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

167

Conditions

Gastric Neoplasm

Interventions

Surgery: abdominal and transhiatal approachPROCEDURE

Surgery: left thoraco-abdominal approachPROCEDURE

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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%

Locations (1)

National Cancer Center Hospital

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

Outcomes

Primary Outcomes

overall survival

Secondary Outcomes

relapse-free survival

operative morbidity and mortality

quality of life

Data from ClinicalTrials.gov

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