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A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
D1 or D2 lymphadenectomy for gastric cancer patients
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Comparison between D1 and D2 lymphadenectomy for gastric cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Patients with biopsy/frozen section proven adenocarcinoma of stomach.

  • 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

Exclusion Criteria:Patients with low performance score

  • 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

Sites / Locations

  • Tata Memorial Hospital,Tata Memorial Centre

Outcomes

Primary Outcome Measures

5 year overall survival

Secondary Outcome Measures

: 5 year disease free survival
: 5 year local recurrence
: Postoperative morbidity and mortality rates

Full Information

First Posted
March 14, 2007
Last Updated
March 14, 2007
Sponsor
Tata Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00447746
Brief Title
A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial
Official Title
A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2014 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tata Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Comparison between D1 and D2 lymphadenectomy for gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
D1 or D2 lymphadenectomy for gastric cancer patients
Primary Outcome Measure Information:
Title
5 year overall survival
Secondary Outcome Measure Information:
Title
: 5 year disease free survival
Title
: 5 year local recurrence
Title
: Postoperative morbidity and mortality rates

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients with biopsy/frozen section proven adenocarcinoma of stomach. 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 Exclusion Criteria:Patients with low performance score 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Parul J Shukla, M.S.,FRCS
Phone
+912224177172
Email
pjshukla@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Shailesh v Shrikhande, M.S.
Phone
+912224177173
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Parul J Shukla, M.S.,FRCS
Organizational Affiliation
Tata Memorial Centre,Mumbai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital,Tata Memorial Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr K M Mohandas, M.D.

12. IPD Sharing Statement

Learn more about this trial

A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial

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