Studying Factors That Affect Tumor Response to Chemotherapy Given Before Surgery in Patients with Pancreatic Cancer

Not yet recruiting

Conditions: Disease of digestive system, unspecified,

Registration Number: CTRI/2025/05/087919

Lead Sponsor: Tata Memorial Centre

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the factors determining tumor response after NAT in patients of PDAC treated with curative intent.	At the end of study

Secondary Outcome Measures

Name	Time	Method
To study the impact of surgical outcome on OS & DFS
To study the impact of pCR on OS & DFS	5 years after the surgery

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Shailesh Shrikhande
Principal investigator
9820224761
shailushrikhande@hotmail.com