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

J

Japan Clinical Oncology Group

Status and phase

Terminated
Phase 3

Conditions

Gastric Neoplasm

Treatments

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

  • histologically proven adenocarcinoma
  • 75 years old or younger
  • forced expiratory volume in one second ≥ 50 %
  • arterial oxygen pressure in room air ≥ 70 mmHg
  • clinically T2/T3/T4 with ≤3 cm esophageal invasion
  • written consent

Exclusion criteria

  • Carcinoma in the remnant stomach
  • Borrmann type 4 (linitis plastica)
  • synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
  • history of left thoracotomy, or left pleural adhesion
  • past history of myocardial infarction or positive results of exercise ECG
  • 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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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