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A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

Primary Purpose

Gastric Neoplasm

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Surgery: D2 dissection
Surgery: D2+paraaortic dissection
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Neoplasm focused on measuring stomach neoplasms, lymph node excision, abdominal aorta

Eligibility Criteria

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

Inclusion Criteria: - Preoperatively, histologically proven adenocarcinoma 75 years old or younger forced expiratory volume in one second ≥ 50 % arterial oxygen pressure in room air ≥ 70 mmHg creatinine clearance ≥ 50 ml/min written consent. Intraoperatively Macroscopic T staging is T2-subserosa, T3, or T4 potentially curative operation is possible no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed) peritoneal lavage cytology is negative for cancer cells 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 past history of myocardial infarction or positive results of exercise ECG liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%

Sites / Locations

  • National Cancer Center Hospital

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

relapse-free survival
operative morbidity and mortality
length of postoperative hospital stay
quality of life

Full Information

First Posted
September 7, 2005
Last Updated
September 20, 2016
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00149279
Brief Title
A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer
Official Title
Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

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 evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy
Detailed 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.

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 excision, abdominal aorta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Surgery: D2 dissection
Intervention Type
Procedure
Intervention Name(s)
Surgery: D2+paraaortic dissection
Primary Outcome Measure Information:
Title
overall survival
Secondary Outcome Measure Information:
Title
relapse-free survival
Title
operative morbidity and mortality
Title
length of postoperative hospital stay
Title
quality of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Preoperatively, histologically proven adenocarcinoma 75 years old or younger forced expiratory volume in one second ≥ 50 % arterial oxygen pressure in room air ≥ 70 mmHg creatinine clearance ≥ 50 ml/min written consent. Intraoperatively Macroscopic T staging is T2-subserosa, T3, or T4 potentially curative operation is possible no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed) peritoneal lavage cytology is negative for cancer cells 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 past history of myocardial infarction or positive results of exercise ECG liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%
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
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15199090
Citation
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. doi: 10.1200/JCO.2004.10.184. Epub 2004 Jun 15.
Results Reference
background
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
PubMed Identifier
18669424
Citation
Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

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