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


Phase 3
N/A
75 Years
Not Enrolling
Both
Gastric Neoplasm

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Trial Information

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


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.


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%

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Principal Investigator

Mitsuru Sasako, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gastric Surgery Division, National Cancer Center Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG9502

NCT ID:

NCT00149266

Start Date:

July 1995

Completion Date:

December 2008

Related Keywords:

  • Gastric Neoplasm
  • stomach neoplasms
  • lymph node resection
  • cardia
  • thoracotomy
  • Neoplasms
  • Stomach Neoplasms

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