A Trial to Evaluate Para-aortic Lymphadenectomy for Gastr... | NCT00149279

Studies
A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

NCT00149279

Sponsor

Japan Clinical Oncology Group

Status

Completed

Last Update Posted

Sep 22, 2016Estimated

Enrollment

520

Phase

Phase 3

Conditions

Gastric Neoplasm

Interventions

Surgery: D2 dissection
Surgery: D2+paraaortic dissection

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
C000000121

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1995

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2016

Last Update Posted Date

Sep 22, 2016Estimated

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

520

Measure	Description	Time Frame
overall survival

Eligibility Module

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%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mitsuru Sasako, MD	Gastric Surgery Division, National Cancer Center Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center Hospital		Chuo-ku	Tokyo	104-0045	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15199090	Background	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.
21104822

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Name	Type	Description	Arm Group Labels	Other Names
Surgery: D2 dissection	Procedure
Surgery: D2+paraaortic dissection	Procedure

Measure	Description	Time Frame
relapse-free survival
operative morbidity and mortality
length of postoperative hospital stay