| 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
|
|
|
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
|
|
|
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. |