CTRI Number |
CTRI/2025/05/087919 [Registered on: 30/05/2025] Trial Registered Prospectively |
Last Modified On: |
28/05/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Retrospective Observational |
Study Design |
Other |
Public Title of Study
|
Studying Factors That Affect Tumor Response to Chemotherapy Given Before Surgery in Patients with Pancreatic Cancer |
Scientific Title of Study
|
Predictors of tumour response to neoadjuvant chemotherapy in resected PDACs
|
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shailesh Shrikhande |
Designation |
Deputy Director TMH, Professor and Surgeon |
Affiliation |
TATA MEMORIAL HOSPITAL |
Address |
Department of Surgical Oncology 3rd floor homibhabha block room number 325 Tata Memorial Hospital Dr E Borges Marg Parel Mumbai INDIA Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai MAHARASHTRA 400012 India |
Phone |
9820224761 |
Fax |
|
Email |
shailushrikhande@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shailesh Shrikhande |
Designation |
Deputy Director TMH, Professor and Surgeon |
Affiliation |
TATA MEMORIAL HOSPITAL |
Address |
Department of Surgical Oncology 3rd floor homibhabha block room number 325 Tata Memorial Hospital Dr E Borges Marg Parel Mumbai INDIA Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai MAHARASHTRA 400012 India |
Phone |
9820224761 |
Fax |
|
Email |
shailushrikhande@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shailesh Shrikhande |
Designation |
Deputy Director TMH, Professor and Surgeon |
Affiliation |
TATA MEMORIAL HOSPITAL |
Address |
Department of Surgical Oncology 3rd floor homibhabha block room number 325 Tata Memorial Hospital Dr E Borges Marg Parel Mumbai INDIA Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai MAHARASHTRA 400012 India |
Phone |
9820224761 |
Fax |
|
Email |
shailushrikhande@hotmail.com |
|
Source of Monetary or Material Support
|
No funding required for this study as retrospective observational study Study being conducted at Tata Memorial Hospital Dr Ernest Borges Marg Parel Mumbai 400012 |
|
Primary Sponsor
|
Name |
Tata Memorial Centre |
Address |
Tata Memorial Centre (TMC), Dr E Borges Marg Parel Mumbai INDIA 400012 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India United States of America |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Shailesh Shrikhande |
Tata Memorial Hospital |
Department of Surgical oncology 3rd floor Homibhaba block room no 325 Tata Memorial Hospital Dr. E Borges Marg Parel Mumbai INDIA Mumbai 400012 MAHARASHTRA
Mumbai
MAHARASHTRA Mumbai MAHARASHTRA |
9820224761
shailushrikhande@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Tata Memorial Hospital Institutional Ethics Committee 2 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Not applicable |
Not applicable |
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
All patients with histology-proven Pancreatic ductal adenocarcinoma who underwent Neoadjuvant chemotherapy with or without neoadjuvant radiotherapy and underwent curative pancreatic resections
The period for recruitment -1st January 2015 to 31st December 2023
|
|
ExclusionCriteria |
Details |
Final histology nonpancreatic ductal adenocarcinoma
Patients who were deemed inoperable during surgical exploration
Tumors epicenter in periampullary region (ampulla of vater, duodenum, distal bile duct)
Treatment date outside of study protocol
Lost to follow up
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess the factors determining tumor response after NAT in patients of PDAC treated with curative intent.
|
At the end of study
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the impact of surgical outcome on OS & DFS
|
5 years after the surgery |
To study the impact of pCR on OS & DFS |
5 years after the surgery |
|
Target Sample Size
|
Total Sample Size="330" Sample Size from India="150"
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)
|
11/07/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
25/07/2025 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Pancreatic ductal adenocarcinoma PDAC is amongst the most lethal solid tumors. Curative treatment, Surgery along with chemotherapy, is feasible in only about 15% of cases since majority of the PDACs are metastatic or locally advanced at presentation. Despite the surgical advancements made in the past few years, multidisciplinary management with neo-adjuvant modalities hold the key for further improving the outcomes for PDAC. Neoadjuvant therapy holds potential in improving rate of margin negative resections R0 and allows for testing tumour biology for selecting patients who will benefit most from major pancreatic resections. In the context of PDAC though evidence is fast building up, there is still a lack of consensus on factors predicting response after neo-adjuvant therapy and in turn its effect on long-term survival. Therefore, it is essential to conduct a multicenter international study to better understand the prognostic factors for long-termsurvival in this group of patients. In this multicenter retrospectivestudy,group of hospitals performing pancreatic surgery will participate by providing data on all the relevant preoperative, operative, and postoperative variables of patients undergoing pancreatectomy for PDAC. In the data collection we will collect information like age, medical history, neo-adjuvant therapy, surgery etc. Patients operated between 2015 and 2023 will be included. Our main goal is identify factors predicting response to neo-adjuvant therapy and its co-relation to survival. |