A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

Gastric Neoplasm Clinical Trial

Official title:

Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149279
• Other study ID #: JCOG9501
• Secondary ID: C000000121
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: September 20, 2016
• Start date: July 1995
• Est. completion date: April 2006

Study information

• Verified date: September 2016
• 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 evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy

Description:

Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Preoperatively,

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. creatinine clearance = 50 ml/min

6. written consent. Intraoperatively

7. Macroscopic T staging is T2-subserosa, T3, or T4

8. potentially curative operation is possible

9. no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed)

10. peritoneal lavage cytology is negative for cancer cells

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. past history of myocardial infarction or positive results of exercise ECG

5. liver cirrhosis, or chronic liver disease with indocyanine green test =10%

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: D2 dissection

• Surgery: D2+paraaortic dissection

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	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)

Sano T, Sasako M, Yamamoto S, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K. Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy--Japan Clinical Oncology Group study 9501. J Clin Oncol. 2004 Jul 15;22(14):2767-73. Epub 2004 Jun 15. — View Citation

Outcome

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

External Links

•   Link