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CTRI Number  CTRI/2026/02/104157 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
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   A study on the feasibility and safety of Intra-Peritoneal Chemotherapy during Ovarian Cancer surgery 
Scientific Title of Study   Feasibility and Safety of Intraoperative Normothermic Intraperitoneal Chemotherapy (NIPEC) following optimal cytoreduction in women with high grade serous epithelial ovarian cancer undergoing interval cytoreductive surgery 
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 Jyothivishnu J L 
Designation  Senior Resident Mch ( Gynaecological Oncology) 
Affiliation  AIIMS, New Delhi 
Address  Dept Of Obstetrics and Gynaecology AIIMS, New Delhi
Ansari Nagar, South Delhi
South
DELHI
110029
India 
Phone  8730026575  
Fax    
Email  jvagmc1988@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Seema Singhal 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Department Of Obstetrics and Gynaecology, All India Institute Of Medical Sciences,New Delhi

South
DELHI
110029
India 
Phone  9818291001  
Fax    
Email  drseemasinghal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Seema Singhal 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Department Of Obstetrics and Gynaecology, All India Institute Of Medical Sciences,New Delhi

South
DELHI
110029
India 
Phone  9818291001  
Fax    
Email  drseemasinghal@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Ansari Nagar, South Delhi Dist, New Delhi, India, Pin :110029 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  Ansari Nagar, South Delhi Dist, New Delhi, India, Pin 110029 
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 Jyothivishnu J L  All India Institute Of Medical Sciences  Department Of Obstetrics and Gynaecology, New Delhi
South
DELHI 		 8730026575

jvagmc1988@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE, AIIMS,NEW DELHI  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  Interval Cyto Reductive Surgery  The comparative arm arm patients will undergo cytoreductive surgery 
Intervention  Normothermic Intraperitoneal Chemotherapy (NIPEC) once in patients undergoing Interval cytoreductive Surgery   The intervention arm will recieve Normothermic Intraperitoneal Chemotherapy (NIPEC) using Inj Cisplatin 75mg/m2 concentration after interval cytoreductive surgery frequency : Once, Duration: 24 hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Patients with advanced high grade serous epithelial carcinoma ovary (Stage III-IV), fallopian tube carcinoma or primary peritoneal cancer with CC0/CC1 resection at the time of interval CRS
2. Age: 18-70 years.
3. ECOG performance status 0-2.
4. Adequate organ function with the following criteria: White blood cell (WBC) more than or equal to 4000/ul; Absolute Neutrophil Count (ANC) more than or equal to1500/ul; Platelet count more than or equal to 100×103/ul;
AST less than or equal to 100 IU/L; (ALT) less than or equal to100 IU/L; Serum total bilirubin less than or equal to 1.5 mg/dL. Serum Creatinine less than 1.2 mg/dl
 
 
ExclusionCriteria 
Details  1.Suboptimal debulking
2.Presence of extra abdominal disease at response assessment precluding complete cytoreduction
3.If Bevacizumab was given during NACT
4. Failure to give consent
5.Non-epithelial or type 1 EOC
6.Pre-existing renal or liver disease
7.Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
8.Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of patients who recieved intraoperative chemotherapy and complete 6 cycles of systemic adjuvant chemotherapy.
2.Total number of chemotherapy cycles received, dose reductions or change in schedule
3. The frequency and severity of adverse events (AEs) within 30days , of grade 3 or higher like anemia, bowel function measures
 		 1.Observe for early toxicity and side
effects for 24 hours
2. Observe for late toxicities at 30 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the post-operative inflammatory & immune marker profiles, including CRP, NLR, PLR, Systemic immune-inflammatory index (SII: NxP/L), & selected T cell populations in patients receiving Interval CRS alone versus CRS with NIPEC.
2.To compare the PROs of bowel functioning, pain, fatigue/lack of energy, abdominal symptoms & burden of disease & treatment assessed using the EORTC QLQ-C30, QLQ-OV28, bowel scales of the QLQ-CR29.

 		 1.Compare immune markers at 0,7, 28 days
2.PROs at 0,7,28 days  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/03/2026 
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="2"
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   Conducting this study is essential to determine whether intraoperative NIPEC can provide a safe and practical intraperitoneal therapy alternative, complement systemic treatment, and potentially improve oncologic outcomes without imposing additional surgical morbidity. Establishing its safety and feasibility is the critical first step before larger trials can evaluate its long-term survival impact, making this investigation both timely and clinically relevant. In the Indian scenario, most patients belong to low socioeconomic class not affordable for HIPEC. In low cost we can provide almost equal results with low morbidity. 
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