| CTRI Number |
CTRI/2024/10/076077 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Chemotherapy Treatment for Pancreatic Cancer from Cyst Growths Intraductal Papillary Mucinous Neoplasms (IPMN) |
|
Scientific Title of Study
|
Multicenter Retrospective Analysis of Adjuvant Chemotherapy Regimen in IPMN derived PDAC |
| 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 |
| 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 |
| 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 |
| Phone |
9820224761 |
| Fax |
|
| Email |
shailushrikhande@hotmail.com |
|
|
Source of Monetary or Material Support
|
| No funding required for this study as retrospective observational study Infrastructure support Tata memorial hospital dr ernest borges marg parel mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
NYU Grossman School Of Medicine |
| Address |
Department of Surgery, NYU Grossman School Of Medicine 530 First Avenue Silverstein 7V New York NY 10016 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
China
Germany
India
Italy
Netherlands
Republic of Korea
Switzerland
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
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 II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D136||Benign neoplasm of pancreas, |
|
|
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 |
75.00 Year(s) |
| Gender |
Both |
| Details |
-Patients with resected IPMN derived PDAC from 2005 to 2022 |
|
| ExclusionCriteria |
| Details |
-Patients below 18 years of age
-Patients with concomitant PDAC, metastatic disease at time of resection, Neoadjuvant therapy or 90 day mortality |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| whether an adjuvant chemotherapy regimen (monotherapy gemcitabine vs. combination gemcitabine vs. FOLFIRINOX) is associated with overall survival in patients with respected IPMN-derived PDAC. |
Overall survival will be calculated as the time between date of the surgery to the date of the last known follow-up visit or death 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence free survival |
Recurrence free survival will be calculated from the date of surgery to the date of documented cancer recurrence or death, whichever comes first |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="50"
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)
|
15/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2024 |
| 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)
|
Open to Recruitment |
| 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
|
A specific subtype of pancreatic cancer called ‘IPMN (intraductal papillary mucinous neoplasms) derived PDAC’ (pancreatic ductal adenocarcinoma), is known to have better prognosis. The role of chemotherapy in this tumor in adjuvant setting (after surgery) slowly getting established. The present study will compare three types of adjuvant chemotherapy one called gemcitabine, another one with combo gemcitabine, and one called FOLFIRINOX after resection in IPMN associated PDAC. At present the chemotherapy regimens for IPMN derived PDAC are extrapolated from what is being used in the data available for the other/standard PDAC (non IMPN derived). Hence, although adjuvant chemotherapy is useful, the appropriate regimen is yet to be identified for IPMN associated PDAC. In this multicenter retrospective study, group of hospitals treating this cancer with different types of chemotherapy regimens will participate by providing data on long term outcomes. Our main goal is to see if one of these chemotherapy types helps people live longer after surgery for IPMN- derived PDAC. We will look at records of patients who had surgery for IPMN-derived PDAC between 2005 to 2022 and were at least 18-year-old. We will not take those patients data that had any other serious complications along with the surgery. In the data collection we will collect information like age, medical history, treatment etc; and then we will see if there is a difference in how long people live or how each of chemotherapy works. We’re hoping this study will give us a clearer picture of which chemotherapy regimen works best for IPMN-derived PDAC. |