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

Gastric Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00149266
• Other study ID #: JCOG9502
• Secondary ID: C000000122
• Status: Terminated
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: February 2, 2009
• Start date: July 1995
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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%

Study Design

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

Related Conditions & MeSH terms

• Gastric Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• Surgery: abdominal and transhiatal approach

• Surgery: left thoraco-abdominal approach

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	5-1-1 Tsukiji, Chuo-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Sasako M, Sano T, Yamamoto S, Sairenji M, Arai K, Kinoshita T, Nashimoto A, Hiratsuka M; Japan Clinical Oncology Group (JCOG9502). Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a random — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival
Secondary	relapse-free survival
Secondary	operative morbidity and mortality
Secondary	quality of life

External Links

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