| CTRI Number |
CTRI/2025/09/094439 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal study design |
| Study Design |
Other |
|
Public Title of Study
|
Outcomes of HIPEC with Cisplatin in advanced ovarian cancers in a tertiary care hospital in India. |
|
Scientific Title of Study
|
Surgical and survival outcomes of patients undergoing CRS +HIPEC with Cisplatin for advanced ovarian cancer in a tertiary care hospital in India. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinash Ramakrishnan |
| Designation |
senior resident |
| Affiliation |
AIIMS, BHOPAL |
| Address |
Dept of surgical oncology,
AIIMS bhopal.
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9543224999 |
| Fax |
|
| Email |
yesarrabhi@gmail,com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinay kumar |
| Designation |
Additional professor and Head of the department. |
| Affiliation |
AIIMS, BHOPAL |
| Address |
Department of surgical oncology, CV RAMAN BUILDING,
AIIMS bhopal.
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9543224999 |
| Fax |
|
| Email |
vinay.surgonco@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Avinash Ramakrishnan |
| Designation |
senior resident |
| Affiliation |
AIIMS, BHOPAL |
| Address |
Dept of surgical oncology,
AIIMS bhopal.
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9543224999 |
| Fax |
|
| Email |
yesarrabhi@gmail,com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), department of surgical oncology, CV raman Building, AIIMS Campus Road, Saket Nagar Bhopal - 462020, Madhya Pradesh, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhopal |
| Address |
Dept of surgical oncology,
AIIMS bhopal
AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh 462020 |
| 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 |
| Avinash S R |
AIIMS Bhopal. |
Department of surgical oncology, CV raman building,
AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh 462020
Bhopal
MADHYA PRADESH |
9543224999
yesarrabhi@gmail,com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Student Research (IHEC-SR), AIIMS Bhopal. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients Aging from 18 to 75 years of age
2)ECOG score less than or equal to 1
3)Primary or recurrent epithelial ovarian cancer
4)Partial or complete Response to perioperative chemotherapy if given (biochemical and imaging)
Imaging by RECIST 1.1 criteria 27
Biochemical by ca125 levels as defined by gynecologic cancer intergroup (GCIG). best combined overall response as given by GCIG will be used
5)Cc score 0/1
|
|
| ExclusionCriteria |
| Details |
1)Stage 4 ovarian cancers
2)Progressive on chemotherapy (biochemical and imaging)
3)ECOG score more than 1. 29
4)Non epithelial histology
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To estimate the incidence of post-surgical complication rate (at 30 days) using the Clavien-Dindo Grading system.
2. To estimate the incidence of early mortality (at 30 days).
3. To assess survival outcomes (eg. recurrence-free median survival duration, recurrence-free median survival rate, incidence density of recurrence, etc.) at one year.
|
1. Incidence of post-surgical complication rate (at 30 days).
2. Incidence of early mortality (at 30 days).
3.survival outcomes at one year.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of chemotoxicity (at 14 days) among participants who undergo HIPEC post-cytoreductive surgery for management of Ovarian cancer |
at 14 days |
| 5. To determine the change in the health-related quality of life (QoL) among patients undergoing CRS + HIPEC between before surgery and at 6 months |
before surgery
6 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
22/09/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Ovarian cancer is 3rd most common cancer among females in India
(over all 9th common) with 5-year prevalence of 17.6/ 1lakh
population. It is a silent cancer with less or
no symptoms in early stages and most of the patients presenting at advanced
stages of disease. Data from hospital-based cancer registries published in 2022, showed
almost 41.9% cases presented in locally advanced stage, 29% with distant
metastasis and only 29% (less than 1/3rd) had localized disease. Even in case of localized
disease, almost 80% of patient will have persistent disease or recurrence. Currently combined treatment
with both cytoreductive surgery(CRS) and chemotherapy remains main stay of
treatment. Intraperitoneal chemotherapy was advocated as high doses of
chemotherapeutic drugs can be administered in peritoneal cavity without much
increase in plasma concentration levels as shown in studies conducted by Dedrick
et al. Studies have shown intraperitoneal
chemotherapy to be improving survival outcomes. But was associated with
peritoneal catheter related complications and sepsis leading to delay and
discontinuation of chemotherapy. Sugar baker et al also showed
administration of chemotherapy with intraperitoneal catheters had incomplete
coverage of peritoneal surface, leading to decreased efficacy. To bypass these difficulties intraoperative
intraperitoneal chemotherapy was proposed just after cytoreduction under
hyperthermic conditions and was found to be have added survival benefits among
patients compared to patients receiving only cytoreductive surgery alone. Most
of the data in this topic is from western countries and data from Indian population
is limited. This current study aims to study the effectiveness of hyperthermic
intraperitoneal chemotherapy (HIPEC) when combined with CRS in Indian
population and early postoperative morbidity and mortality associated with it
and quality of life of patients undergoing HIPEC, compared to CRS alone. |