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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Esophageal & Gastroesophageal cancer patients who have already received chemoradiation , |
|
Intervention / Comparator Agent
|
|
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 |
|
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. |