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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 


 
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