| CTRI Number |
CTRI/2013/03/003461 [Registered on: 07/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of Her 2 testing on pathology of patients with gastric cancer |
|
Scientific Title of Study
|
"An observational study to determine the incidence of Her2 positivity in 100 consecative gastric cancers" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1077 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Consultant Medical Oncologist |
| Affiliation |
Consultant Medical Oncologist |
| Address |
TATA MEMORIAL HOSPITAL
DR E BORGES MARG PAREL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-9930033980 |
| Fax |
|
| Email |
bhawna.sirohi@btinternet.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhawna Sirohi |
| Designation |
Consultant Medical Oncologist |
| Affiliation |
|
| Address |
TATA MEMORIAL HOSPITAL
DR E BORGES MARG PAREL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-9930033980 |
| Fax |
|
| Email |
bhawna.sirohi@btinternet.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhawna Sirohi |
| Designation |
Consultant Medical Oncologist |
| Affiliation |
|
| Address |
TATA MEMORIAL HOSPITAL
DR E BORGES MARG PAREL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-9930033980 |
| Fax |
|
| Email |
bhawna.sirohi@btinternet.com |
|
|
Source of Monetary or Material Support
|
| Roche India private limited. The study is Extramural and have unrestricted Educational grants from Roche India private limited
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial centre |
| Address |
Tata Memorial Centre
Dr Ernest Borges Marg Parel Mumbai
400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhawna Sirohi |
Tata Memorial hospital |
Dr Bhawna sirohi
consultant medical oncologist
GI and Breast unit
Room No 1105 Homibhaba building
Dr Earnest Borges Marg Parel
Mumbai:-400012
Mumbai
MAHARASHTRA |
91-9930033980
bhawna.sirohi@btinternet.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Tata Memorial centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
gastric cancer, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
100 consecutive patients with gastric cancer who have a pathology specimen at our site |
|
| ExclusionCriteria |
| Details |
If histopathology blocks were not available |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Her2 positivity in 100 consecutive Gastric cancer patients |
Total duration of 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be updated after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. We 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, we plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients. | Study | Population | N | Histology type | | | Location | | | | | | Intestinal (% +) | Diffuse (%+) | Mixed/Uk (%+) | GEJ | Stomach | | Tanner (1) | Finland | 231 | 21.5 | 2 | 5 | 24 | 12 | | Gravalos (2) | Spain | 166 | 16 | 7 | 14 | 25 | 9.5 | | Lordick (3) | International | 1527 | 34 | 6 | 20 | 32 | 18 | | Matsubara (4) | Japan | 87 | 32.5 | 6 | | | | | Park (5) | Korea | 161 | 8 | 1 | | | | | | | | | | | | | |