FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/059184 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Cytoreductive surgery and heated intraperitoneal chemotherapy in relapsed epithelial ovarian cancer – Randomised control trial  
Scientific Title of Study   Cytoreductive surgery and HIPEC in relapsed epithelial ovarian cancer – a phase III randomised control trial and descriptive study to evaluate effect of HIP3C in HRD/BRCAwt genomic profile 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divyam Goel 
Designation  senior resident 
Affiliation  Department of surgical oncology, AIIMS, Delhi 
Address  Department of surgical oncology, B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8586015266  
Fax    
Email  divyamgo@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  M D Ray 
Designation  Professor 
Affiliation  Department of surgical oncology, AIIMS, Delhi 
Address  Department of surgical oncology, B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8586015266  
Fax    
Email  drmajormdrayaiimsdelhi@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Divyam Goel 
Designation  senior resident 
Affiliation  Department of surgical oncology, AIIMS, Delhi 
Address  Department of surgical oncology, B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8586015266  
Fax    
Email  divyamgo@gmail.com  
 
Source of Monetary or Material Support  
B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi 
 
Primary Sponsor  
Name  BR Ambedkar Institute Rotary Cancer Hospital BRAIRCH 
Address  Department of surgical oncology, BRAIRCH, AIIMS, New Delhi 
Type of Sponsor  Government medical college 
 
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 Divyam Goel  AIIMS, Delhi  Department of Surgical oncology, BRAIRCH, AIIMS, New Delhi
South
DELHI 		 8586015266

divyamgo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for biomedical and health research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cytoreductive surgery only  only cytoreductive surgery is done 
Intervention  HIPEC  HIPEC - heated intraperitoneal chemotherapy is given intraoperatively after completion of cytoreductive surgery Dose - cisplatin at 70mg/sqm, frequency- single time administration, duration - 90 min, route of administration - intraperitoneally 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1. Patients with recurrent epithelial ovarian cancer
2. Biochemical, radiological or clinical recurrence
3. Patients satisfying the selection criteria score of >6 taking into account the parameters mentioned in the following table.

Components Score
Performance status 0 3
1 2
Optimized 2 1
>2 0
CT PCI ≤8 3
9-12 2
13-15 1
≥16 0
Progression free Interval >18 mo 3
12-18 mo 2
6-12 mo 1
<6 mo 0
Prior optimal CRS CC-0 3
CC-1 2
CC-2 1
CC-3 0
CA 125 at relapse Normal 1
Elevated 0
Symptomatic status Asymptomatic 1
Symptomatic 0
Total 14
 
 
ExclusionCriteria 
Details  1. Platinum resistant disease
2. Patients who have received chemotherapy after detection of recurrence
3. Extraabdominal recurrent disease
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC  To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare overall survival in two arms
2.To compare duration of hospital stay post operatively in two arms
3.To compare post operative complications in two arms 		 1.Overall survival
2.Duration of hospital stay post operatively
3.Post operative complications
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   06/11/2023 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [divyamgo@gmail.com].

  6. For how long will this data be available start date provided 01-10-2023 and end date provided 30-09-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The most common type of ovarian cancer is epithelial ovarian cancer (EOC) worldwide. The current standard treatment consists of complete Cytoreductive surgery with platinum-based chemotherapy (intravenous and intraperitoneal). Hyperthermic intraperitoneal chemotherapy (HIPEC) delivers heated chemotherapy drugs into the peritoneal cavity after the complete removal of the tumor (i.e. cytoreduction). HIPEC has become the advanced treatment modality for peritoneal surface malignancy like ovarian cancer, with a survival benefit noted in primary and recurrent tumors. Recently, response to HIPEC has been evaluated among different genomic profiles and patients with HRD tumors without pathogenic BRCA1/2 mutation appear to benefit most. In the recurrent disease, secondary CRS and HIPEC have emerged as promising treatment options  to improve outcomes. There is still some controversy regarding their efficacy, safety, and patient selection criteria.

Our study aims to evaluate the role of HIPEC in secondary CRS in recurrent epithelial ovarian cancers in terms of treatment response and to evaluate effect of HIPEC in HRD/BRCAwt genomic profile in these patients. The findings of this study could potentially inform clinical practice and contribute to the development of evidence-based guidelines for the management of recurrent epithelial ovarian cancer.

 
Close