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CTRI Number  CTRI/2025/09/094629 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A single centre retrospective observational study to find out the diffrent Management strategies used in sarcoma (a type of soft tissue cancer) treatment arising in the back of abdomen that come back after the initial treatment 
Scientific Title of Study   Management of Recurrent Retroperitoneal Sarcomas: A retrospective study from a Tertiary Cancer Center. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 901186 V2.0 dated 08.08.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Patkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Dept of Surgical Oncology, GI DMG, 3rd floor, Homi Bhabha Building, Dr E Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shraddha Patkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Dept of Surgical Oncology, GI DMG, 3rd floor, Homi Bhabha Building, Dr E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shraddha Patkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Dept of Surgical Oncology, GI DMG, 3rd floor, Homi Bhabha Building, Dr E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road, Parel, Mumbai, Maharashtra, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shraddha Patkar  Advanced Centre for Treatment Research & Education in Cancer  OPD no 324, Dept of Surgical Oncology, GI DMG, 3rd Floor, Asha Sadan, Kharghar
Mumbai (Suburban)
MAHARASHTRA 
9820074818

drshraddhapatkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Advanced Centre for Treatment Research and Education in Cancer-Institutional Ethics Committee 3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C480||Malignant neoplasm of retroperitoneum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Consecutive adult patients (18 years and above) of both sexes with patients with Recurrent RP sarcomas.
2. Date of surgery between January 2011 to December 2024
 
 
ExclusionCriteria 
Details  1. Non-retroperitoneal, intra-abdominal sarcomas
2. Chemo-sensitive and radiosensitive histologies like Ewing’s sarcoma which have management protocols different from other RP sarcomas.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Overall survival in patients with recurrent retroperitoneal sarcomas and retroperitoneal sarcoma with multiple recurrences   after surgery for first 2 years after every 3 months, then every 6 month for next 3 yrs and then every year 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of factors associated with multiple recurrences   after surgery for first 2 years after every 3 months, then every 6 month for next 3 yrs & then every year 
Difference in OS between Rec RPS after adequate surgery Vs Rec RPS after inadequate surgery  after surgery for first 2 years after every 3 months, then every 6 month for next 3 yrs & then every year 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
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)   30/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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 Applicable 
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  

Study title: Management of Recurrent Retroperitoneal Sarcomas:  A retrospective study from a Tertiary Cancer Center.

Short title: Management of Recurrent Retroperitoneal Sarcomas

Type of study: Retrospective observational study

Retroperitoneal Sarcomas (RPS) are a complex heterogenous group of relatively uncommon tumors. Owing to their complexity and rarity the optimal management of these tumours is restricted to very few dedicated high-volume centers. As a result, a large number of patients present to our center with recurrent disease. Additionally, even after optimal treatment done at high-volume centers these tumors have a high propensity for recurrence.

While there have been substantial milestones achieved in the treatment of primary RPS resulting in development of collaborative efforts, both at institutional level (in the form of dedicated RP clinics) and at internation level (in the for Transatlantic retroperitoneal sarcoma working group guidelines), there is substantial dearth of literature and consensus on the optimal strategies for management of recurrent RPS (rec RPS). It is therefore crucial to audit the outcomes of patients undergoing surgical treatment for rec RPS, in order to identify the optimal treatment strategies in terms of extent and number of re-resections and adjuvant treatment options for these patients.

This is a single center retrospective study, aims to evaluate the outcomes of rec RPS sarcomas (RPS). The results of this study are expected to answer this important question of benefit and futility of surgical excision in patients with multiple local recurrences of RPS and thereby guide optimal treatment strategies.

 
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