NCT00447746

Brief Summary

Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible. However the results of surgery are generally disapointing in most large series.The exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortality.The extent of surgery and particularly the development of systematic lymphadenectomy(D2)has been credited in Japan for the improved outcome in patients with gastric cancer. Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in terms of overall survival,disease free survival and loco regional recurrence and also post operative morbidity and mortality following both these procedures,this study has been undertaken. In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will also be removed according to internationally accepted guidelines and also include resection of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto its attachment to hepatoduodenal ligament. Currently both these procedures are widely practised worldwide and there is no definite evidence showing the superiority of one procedure over the other.Neither is any of these procedures experimental. We are doing this trial to see whether one of these procedures is superior to the other.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 15, 2007

Status Verified

March 1, 2007

First QC Date

March 14, 2007

Last Update Submit

March 14, 2007

Conditions

Gastric Cancer

Keywords

Comparison between D1 and D2 lymphadenectomy for gastric cancer

Outcome Measures

Primary Outcomes (1)

  • 5 year overall survival

Secondary Outcomes (3)

  • : 5 year disease free survival

  • : 5 year local recurrence

  • : Postoperative morbidity and mortality rates

Interventions

D1 or D2 lymphadenectomy for gastric cancer patientsPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preoperative clinical examination and imaging indicating operable disease.
  • Intraoperative exploration indicating operability i.e. no peritoneal deposits,no evidence of para aortic lymphadenopathy,no direct involvement of contiguous organs
  • Surgical plan for distal/proximal/total gastrectomy

You may not qualify if:

  • Staging investigations or intraoperative exploration indicating inoperable disease
  • Patients medically unfit for major surgery
  • Patients who have been given preoperative chemotherapy/chemoradiation.
  • Patients with gastroesophageal junction tumours
  • Patients unreliable for follow up
  • Patients above the age of 70 years
  • Past history of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital,Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Dr Parul J Shukla, M.S.,FRCS

    Tata Memorial Centre,Mumbai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Parul J Shukla, M.S.,FRCS

CONTACT

+912224177172pjshukla@hotmail.com

Dr Shailesh v Shrikhande, M.S.

CONTACT

+912224177173

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 15, 2007

Study Start

March 1, 2007

Study Completion

March 1, 2014

Last Updated

March 15, 2007

Record last verified: 2007-03

Locations

IN(1)