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CTRI Number  CTRI/2014/07/004776 [Registered on: 25/07/2014] Trial Registered Retrospectively
Last Modified On: 18/09/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Analysis of patients who have already received Chemo & radiation for esophageal & gastroesophageal junction cancer  
Scientific Title of Study   RETROSPECTIVE ANALYSIS OF PATIENTS WHO HAVE RECEIVED RADICAL CONCURRENT CHEMORADIATION FOR ESOPHAGEAL AND GASTROESOPHAGEAL JUNCTION CANCER  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vanita Noronha 
Designation  Associate Professor & Medical Oncologist  
Affiliation  Tata Memorial Hospital  
Address  Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-400012
Tata Memeorial Hospital, Dr E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India 
Phone  09769328047  
Fax  022-24171734  
Email  vanita.noronha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vanita Noronha 
Designation  Associate Professor & Medical Oncologist  
Affiliation  Tata Memorial Hospital  
Address  Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-400012
Tata Memeorial Hospital, Dr E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India 
Phone  09769328047  
Fax  022-24171734  
Email  vanita.noronha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vanita Noronha 
Designation  Associate Professor & Medical Oncologist  
Affiliation  Tata Memorial Hospital  
Address  Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-400012
Tata Memeorial Hospital, Dr E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India 
Phone  09769328047  
Fax  022-24171734  
Email  vanita.noronha@gmail.com  
 
Source of Monetary or Material Support  
Not applicable  
 
Primary Sponsor  
Name  Not Applicable  
Address  Not Applicable  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable    
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vanita Noronha  Tata Memorial Hospital  Tata Memorial Hospital,Room no 303, 3 rd floor,Department of medical oncology Dr E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 
09769328047
022-24171734
vanita.noronha@gmail.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  Esophageal & Gastroesophageal cancer patients who have already received chemoradiation ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  We will include all patients who have received chemotherapy at Tata Memorial Hospital concurrently with radical radiotherapy for esophageal and GE junction carcinoma, from January 2011 onwards (to date), whose data has been prospectively entered in a database that has been maintained in the medical oncology department at Tata Memorial Hospital. 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary objective:-
To assess the toxicity of weekly Carboplatin and Paclitaxel in combination with radical radiotherapy in patients with esophageal and GE junction cancer.
 
Acute toxicity weekly while on CTRT
Then at 6 weeks after completion of CTRT
Then every 3 months for first 2 years and
At any point in between as needed. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objectives:-
1. Overall survival
2. Progression-free survival
3. Response rate
4. Evaluate factors that affect toxicity.
5. Evaluate factors that affect survival.
 
Yes we will assess mortality at 1 year , 3 years 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/01/2011 
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)
Modification(s)  
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  

At TMH, we treat patients with locally advanced esophageal cancer of the upper third esophagus or CA involving the middle or lower third of the esophagus or GE junction, that is not felt to be amenable to resection in the multidisciplinary clinic, with definitive radical chemoradiotherapy. Patients with locally advanced esophageal or gastroesophageal junction cancer who have undergone surgical resection, may also be advised adjuvant concurrent chemoradiotherapy based on various features in the histopathology report or based on decision made in the joint clinic.5

Since January 2011, we have maintained a prospective database of patients treated with radical concurrent chemoradiotherapy. We wish to analyze this data retrospectively.

We will include all patients who have received chemotherapy at Tata Memorial Hospital concurrently with radical radiotherapy for esophageal and GE junction carcinoma, from January 2011 onwards (to date), whose data has been prospectively entered in a database that has been maintained in the medical oncology department at Tata Memorial Hospital.

 
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