| CTRI Number |
CTRI/2024/08/072237 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Chemotherapy inside the abdomen after surgery in patients with ovarian cancer to reduce chances of disease coming back |
|
Scientific Title of Study
|
Post-operative intraperitoneal chemotherapy after interval cytoreduction in epithelial ovarian cancer (POICE 2024): multicenter, randomized, phase III trial |
| Trial Acronym |
POICE 2024 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Medical Oncology 3rd Floor SS Block
Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09444216310 |
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Medical Oncology 3rd Floor SS Block
Dhanvantri Nagar
PONDICHERRY
605006
India |
| Phone |
09444216310 |
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rebekah C |
| Designation |
Research Fellow |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Medical Oncology 3rd Floor SS Block
Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09444216310 |
| Fax |
|
| Email |
poice2024@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Cancer Grid
Tata Memorial Hospital,
10th Floor, Homi Bhabha Block,
Dr. Ernest Borges Rd, Parel East,
Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER |
| Address |
Dhanvantri Nagar
Gorimedu
Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amit Sehrawat |
AIIMS Rishikesh |
Virbhadra Road Rishikesh
Dehradun
Dehradun
UTTARANCHAL |
01352462940
dramitsehrawat@gmail.com |
| Mukurdipi Ray |
All India Institute of Medical Sciences New Delhi |
Department of Surgical Oncology
RCC Block AIIMS
Ansari Nagar New Delhi 110029
New Delhi
DELHI |
9716772975
drmajormdrayaiimsdelhi@aiims.edu |
| Dr Anoj Kattukaran |
Amala Institute of Medical Sciences |
SH69, Amalanagar, Thrissur, Kerala 680555
Thrissur
KERALA |
9387157174
agkatt@hotmail.com |
| Keechilat Pavithran |
Amrita Institute of Medical Sciences |
Elamakkara PO
Kochi 682041
Ernakulam
KERALA |
9895367090
drkpavithran@hotmail.com |
| R Rajagopalan |
Basavatarakam Indo American Cancer Hospital and Research Institute |
Department of Surgical Oncology
Road No 10
Banjara Hills
Hyderabad 34
Hyderabad
TELANGANA |
9885134239
rajagopalan99@gmail.com |
| Soumya Surath Panda |
IMS and SUM Hospital |
Shampur Bhubaneswar Odisha 751003
Khordha
Khordha
ORISSA |
6742386281
dr.ssp82@gmail.com |
| Prasanth Ganesan |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
DEPARTMENT OF MEDICAL ONCOLOGY SSB 3RD FLOOR Dhanvantri Nagar Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Pondicherry
PONDICHERRY |
9444216310
pg1980@gmail.com |
| Nandini Devi |
Malabar Cancer Center |
Medical Oncology
Moozhikkara PO
Thalassery
Kerala 670103
Kannur
KERALA |
9496369909
drnandiniamutha@gmail.com |
| Krishnakumar Rathinam |
Meenakshi Mission Hospital and Research Institute |
Lake Area Melur Main Road Madurai TN 625107
Madurai
Madurai
TAMIL NADU |
04524263000
kkrathnam@gmail.com |
| Dr Ravidra Babu |
Omega Cancer Hospital - Kurnool |
518003, Nandikotkur Rd, Maruthi Nagar, Sree Rama Nagar, Kurnool, Andhra Pradesh 518002
Kurnool
ANDHRA PRADESH |
8309530009
ravi.mch@gmail.com |
| Prasanth Penumadu |
Sri Venketeswara Institute of Cancer Care and Advanced Research |
Zoo Park Road
Tirupati
AP 517501
Chittoor
ANDHRA PRADESH |
9042092936
drpenumadu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| AIIMS New Delhi |
Approved |
| Ethics Committee of Amrita School of Medicine |
Approved |
| IEC Amala Institute of Medical Sciences |
Approved |
| IMS and SUM Hospital |
Approved |
| INstitutional Ethics Committee SVICCAR |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE- Interventional Studies JIPMER |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE-ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE-Madurai Mission Hospital and Research Centre |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE-MALABAR CANCER CENTRE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEEE-BIACH & RI |
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 |
post-surgery intraperitoenal (IP) chemotherapy |
normothermic intraperitoneal cisplatin at 100 mg per m2 instilled within the abdomen for 60 minutes after surgery |
| Comparator Agent |
surgery alone without any intraperitoneal chemotherapy |
only surgery will be done and no intraperitoneal chemotherapy will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patient giving informed consent
Newly diagnosed FIGO stage 3 or 4a epithelial ovarian cancer
After optimal cytoreduction after interval surgery
Must have received 3 or 4 cycles of paclitaxel nd carboplatin neoadjuvant chemotherapy
ECOG performance status 0 or 1 at enrolment
Negative pregnancy test in women of child bearing potential
adequate organ function
|
|
| ExclusionCriteria |
| Details |
Prior surgery for ovarian cancer other than biopsies
Serious medical illnesses
Uncontrolled infections
Pre existing neuropathy more than grade 1
Known to have borderline or low grade cancer
Prior partial therapy elsewhere
intraoperative complications rendering patient unfit for IP chemotherapy
Time from last chemotherapy to surgery less than 8 weeks
Bevacizumab as part of neoadjuvant schedule |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relapse free survival |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall survival |
3 years |
| toxicity of therapy |
6 months |
| surgical morbidity |
1 month |
| quality of life |
6 months |
|
|
Target Sample Size
|
Total Sample Size="342"
Sample Size from India="342"
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)
|
26/08/2024 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This is a study which will be done in patients with advanced epithelial ovarian cancer who have received 3-4 cycles of chemotherapy with paclitaxel and carboplatin prior to surgery and now planned for surgery. The patients who are eligible and who provide informed consent will undergo standard cytoredcutive surgery. After surgery, if optimal cyoreduction is done, they will be randomised to one of the 2 groups. In group 1 (intervention) they will receive 100 mg per m2 of cisplatin intraperitoneally which will be evacuated after a period of 60 minutes. In group 2, there will be surgery only and no intraperitoneal therapy will be applied. Both groups will receive standard postoperative care. Subsequently they will be followed up till completion of their remaining cycles of (total 6 cycles) of IV chemotherapy. Subseuquently both groups will be followed up as per standard process for the next 3 years to see whether there is any relapse. The relapse free survival between the two groups will be compared. |