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CTRI Number  CTRI/2025/07/090676 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative analysis of the the benefits of intervention with normothermic intraperitoneal chemotherapy in primary cytoreductive surgery for participants with advanced epithelial ovarian cancer- A Pilot study 
Scientific Title of Study   Comparative analysis of normothermic intraperitoneal chemotherapy in primary cytoreductive surgery for advanced epithelial ovarian cancer- A Pilot study 
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 Devika J Kamat 
Designation  MCh fellow 
Affiliation  AIIMS Rishikesh 
Address  Dept of Obs and Gyn AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  09850677033  
Fax    
Email  devika.kamat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Shalini Rajaram 
Designation  Professor and Guide 
Affiliation  AIIMS Rishikesh 
Address  Dept of Obs and Gyn AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  9810704434  
Fax    
Email  rajaram.shalini@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Shalini Rajaram 
Designation  Professor and Guide 
Affiliation  AIIMS Rishikesh 
Address  Dept of Obs and Gyn AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  9810704434  
Fax    
Email  rajaram.shalini@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Rishikesh Virbhadra road, Rishikesh Uttarakhand India 249202 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh 
Address  AIIMS, Virbhadra road, Rishikesh -249202 
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 
Devika J Kamat  All India Institute of Medical Sciences Rishikesh  Dept of Obs & Gyn AIIMS Rishikesh
Dehradun
UTTARANCHAL 		 09850677033

devika.kamat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  normothermic intraperitoneal chemotherapy administration during primary cytoreduction surgery   Eligible patients of advanced epithelial ovarian malignancy who have achieved optimum cytoreduction during primary cytoreduction surgery will receive normothermic intraperitoneal cisplatin at 100mg/sqm chemotherapy at the end of surgery for 60 minutes in a single sitting followed by the standard adjuvant IV chemotherapy with carboplatin and paclitaxel q21d 
Comparator Agent  primary cytoreduction surgery  eligible patients will undergo primary complete cytoreduction surgery and not receive intraperitoneal chemotherapy at the end of surgery followed by the standard adjuvant IV chemotherapy with carboplatin and paclitaxel q21d 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1) Epithelial ovarian or fallopian tube or primary peritoneal cancer FIGO 2023 stage III to IVA clinically or radiologically
2)Optimum cytoreduction i.e. R0 or R1(no macroscopic disease visible) achievable during upfront cytoreduction
3)Good performance score, ECOG 2 or less 
 
ExclusionCriteria 
Details  1)Non epithelial cancer or borderline ovarian cancer
2)FIGO 2023 Stage I or II or IVB of epithelial ovarian, fallopian tube or primary peritoneal cancer
3)Serious intercurrent illness or medical condition
4)No prior diagnosis or treatment of any other cancer within last five years
5) ECOG 3 or more
6) Diffuse infiltration of stomach, dueodenum, head or middle of pancrease
7)Involvement of celiac trunk, hepatic arteries, left gastric artery, liver hilum, lung parenchyma metastasis, unresectable lymph nodes or brain metastasis
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Intraoperative adverse events graded according to Common terminology criteria for adverse events CTCAE 5.0.
2)Postoperative adverse events (within 30 days) according to Clavien Dindo classification
3)Duration of hospital stay in days
4)Preoperative and post-surgery CA-125(U/ml) values after four weeks in both groups.
 		 30 days, 60 days, 6 months and 12 months from the date of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To calculate the delay in days from the day of surgery until 1st cycle of adjuvant intravenous chemotherapy
2. To calculate the disease recurrence rate from the time of surgery up to 12 months during follow-up
3. Quality of life as determined by EQ5D5L questionnaire
 		 30 days, 60 days, 6 months and 12 months from the date of surgery 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 2 
Date of First Enrollment (India)   25/07/2025 
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="6"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 07-07-2025 and end date provided 07-07-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The trial is a randomised open label pilot exploratory study on comparative analysis of intraperitoneal administration of normothermic chemotherapy primary cytoreductive surgery in patients with advanced ovarian malignancy. Primary outcome is to compare intraoperative and postoperative events in both the arms. Secondary obejctives are to compare the recurrent rates and the time to subsequent adjuvant treatment  and quality of life in both the arms. Study is based on the hypothesis that morbidity and complication rates are not increased with improvement in recurrence rates with the addition of a single sitting of normothermic intraperitoneal chemotherapy 
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