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

Japan Clinical Oncology Group

Status and phase: Terminated; Phase 3

Conditions: Gastric Neoplasm

Treatments: Procedure: Surgery: abdominal and transhiatal approach; Procedure: Surgery: left thoraco-abdominal approach

Study type: Interventional

Funder types: Other

Identifiers

NCT00149266

C000000122

JCOG9502

Details and patient eligibility

About

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

Full 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.

Enrollment: 167 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)