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CTRI Number  CTRI/2014/09/004993 [Registered on: 08/09/2014] Trial Registered Retrospectively
Last Modified On: 04/09/2014
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Treatment and outcome of patients with locally advanced or metastatic gall bladder cancer at Tata hospital 
Scientific Title of Study   A retrospective analysis of clinical characteristics, treatment and outcome of patients with locally advanced or metastatic gall bladder cancer treated at Tata Memorial Centre, Mumbai from January 2012 to Oct 2013. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailesh V Shrikhande  
Designation  Professor and GI HPB Surgeon  
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre 12th Floor Homibhaba Buidling Room No 1222 Dr Ernest Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820224761  
Fax    
Email  shailushrikhande@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Singh 
Designation  Senior Resident Medical Oncology 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre 12th Floor Homibhaba Buidling Room No 1222 Dr Ernest Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820224761  
Fax    
Email  todrashish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh V Shrikhande  
Designation  Professor and GI HPB Surgeon  
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Centre 12th Floor Homibhaba Buidling Room No 1222 Dr Ernest Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820224761  
Fax    
Email  shailushrikhande@hotmail.com  
 
Source of Monetary or Material Support  
Investigator intiated study (Postgraduate Thesis 
 
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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Vinayak Shrikhande  Tata Memorial Centre  12TH FLOOR HOMIBHABA,ROOM NO 1222,TATA MEMORIAL CENTRE DR ERNEST BORGES MARG PAREL, MUMBAI 400012 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9820224761

shailushrikhande@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Gall bladder cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  -Advanced Gallbladder carcinoma.
-Have been treated with institution-specific chemotherapy-regimen or best supportive care.  
 
ExclusionCriteria 
Details  -Patients who were partially treated outside.
-Patients who had localized resectable disease at presentation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Overall survival of patients with advanced gallbladder carcinoma
-To study the clinical characteristic in patients with advanced gall bladder cancer 		 date of diagnosis till date of death  
 
Secondary Outcome  
Outcome  TimePoints 
-Progression free Survival
-Prognostic factors related to outcome of patients if any. 		 date of Diagnosis till date of death/recurrence 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Gallbladder cancer (GBC) is a growing health problem in various parts of northern India. When diagnosed more than70- 90% gallbladder cancers are advanced and are beyond surgical resection, which is the only curative option presently. With median survival of less than one year, GBC is one of most aggressive cancers. Currently Gemcitabine combined with platinum is considered as the first line therapy in unresectable and metastatic gallbladder cancer based on recent reports of survival benefit.  Chemotherapy trials in the past have combined different biliary tract cancers including cholangiocarcinomas, hence studies dealing only with GBC are very few. We have the unique experience of treating patients with advanced GBC with standardized gemcitabine-platinum based regimen. This retrospective review will focus on looking at response rates and survival within this group of patients over a time period of Jan 2012 to Oct 2013. 
Primary Objective
-To study the clinical characteristics of patients with advanced gallbladder carcinoma
-To determine the response rate with Gemcitabine-Platinum chemotherapy,toxicity, Progression free survival and overall survival of patients with advanced gallbladder carcinoma

Secondary Objective 
-Prognostic factors related to outcome of patient if any

Study methodology:

All previously untreated patients with advanced gallbladder carcinoma, if suitable are treated with Gemcitabine-Platinum (cisplatin or oxaliplatin) combination.The subjects included in the study will be analyzed with respect to their demographic parameters, presenting clinical features, baseline haematological, biochemical,radiological and pathological features, treatment toxicity and outcomes.

Case records and prospectively entered data of all patients from Jan. 2012 to Oct 2013  who have received treatment including palliative chemotherapy in accordance with the inclusion and exclusion criteria would be screened for clinical characteristics, sex, ECOG PS, Pathology (adenocarcinoma versus others), extent of disease involvement, the outcome of interest (Overall survival [OS],Progression free survival[PFS], Response rate[RR] and toxicity). OS would be defined from the date of diagnosis till date of death due to any cause. All patients who were considered for chemotherapy and given the option of chemotherapy would be included in the analysis. For overall survival Kaplan Meier estimator curves would be generated. Clinical factors and laboratory factors individual would be tested with log-rank test. Those factors which prognosticated for OS would be then tested in a Cox proportional Hazard method for multivariate analysis. For response rates Fischers exact t test or Chi square or Mann Whitney would be used as appropriate. Those factors which show a significant association would be then tested with logistic regression analysis. Interaction test would be used to identify which factors predict response to chemotherapy.   

 
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