Back to results

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

Primary Purpose

Gastric Neoplasm

Status

Terminated

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Surgery: abdominal and transhiatal approach

Surgery: left thoraco-abdominal approach

About this trial

This is an interventional treatment trial for Gastric Neoplasm focused on measuring stomach neoplasms, lymph node resection, cardia, thoracotomy

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

National Cancer Center Hospital

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

relapse-free survival

operative morbidity and mortality

quality of life

Full Information

NCT ID

NCT00149266

First Posted

September 7, 2005

Last Updated

February 2, 2009

Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

1. Study Identification

Unique Protocol Identification Number

NCT00149266

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Terminated

Study Start Date

July 1995 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Neoplasm

Keywords

stomach neoplasms, lymph node resection, cardia, thoracotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Surgery: abdominal and transhiatal approach

Intervention Type

Procedure

Intervention Name(s)

Surgery: left thoraco-abdominal approach

Primary Outcome Measure Information:

Title

overall survival

Secondary Outcome Measure Information:

Title

relapse-free survival

Title

operative morbidity and mortality

Title

quality of life

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitsuru Sasako, MD

Organizational Affiliation

Gastric Surgery Division, National Cancer Center Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

National Cancer Center Hospital

City

5-1-1 Tsukiji, Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

16887481

Citation

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 randomised controlled trial. Lancet Oncol. 2006 Aug;7(8):644-51. doi: 10.1016/S1470-2045(06)70766-5.

Results Reference

result

PubMed Identifier

25605628

Citation

Kurokawa Y, Sasako M, Sano T, Yoshikawa T, Iwasaki Y, Nashimoto A, Ito S, Kurita A, Mizusawa J, Nakamura K; Japan Clinical Oncology Group (JCOG9502). Ten-year follow-up results of a randomized clinical trial comparing left thoracoabdominal and abdominal transhiatal approaches to total gastrectomy for adenocarcinoma of the oesophagogastric junction or gastric cardia. Br J Surg. 2015 Mar;102(4):341-8. doi: 10.1002/bjs.9764. Epub 2015 Jan 21.

Results Reference

derived

PubMed Identifier

21104822

Citation

Kurokawa Y, Sasako M, Sano T, Shibata T, Ito S, Nashimoto A, Kurita A, Kinoshita T; Japan Clinical Oncology Group. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011 Feb;98(2):239-45. doi: 10.1002/bjs.7297.

Results Reference

derived

Links:

URL

http://www.jcog.jp/

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs