Her 2 Testing in Indian Patients With Gastric Cancer
"An Observational Study to Determine the Incidence of of Her 2 Positivity in 100 Consecutive Gastric Cancers"
2 other identifiers
observational
100
1 country
1
Brief Summary
Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. The investigators have very few options for patients with advanced disease. The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas. Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 27, 2017
April 1, 2017
3.7 years
February 27, 2013
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Her2 testing in Gastric cancer
Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
6 month
Eligibility Criteria
100 consecutive Gastric Cancer
You may qualify if:
- consecutive patients with gastric cancer who have a pathology specimen at TMH
You may not qualify if:
- If histopathology blocks were not available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Bhawna Sirohi, MBBS DCH
Consulting Medical Oncologist
- PRINCIPAL INVESTIGATOR
Shailesh Shrikhande, MS
Professor of Surgical GI and HPB surgery
- PRINCIPAL INVESTIGATOR
Mukta Ramadwar, MD
Consultant Pathologist
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consulting Medical Oncologist
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 19, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
April 27, 2017
Record last verified: 2017-04