| CTRI Number |
CTRI/2025/07/090264 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Total peritonectomy versus peritoneal biopsies in interval cytoreduction |
|
Scientific Title of Study
|
Comparative analysis of peritonectomy techniques in detection of occult peritoneal disease in Interval cytoreductive surgery for advanced ovarian cancer (ToPIC)-An Exploratory randomised study |
| Trial Acronym |
ToPIC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Amrita Gaurav |
| Designation |
Additional Professor |
| Affiliation |
All India institute of medical sciences, Rishikesh |
| Address |
Department of Obstetrics and Gynaecology, AIIMS,Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9506898204 |
| Fax |
|
| Email |
aamrity@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jaya Chaturwedi |
| Designation |
Professor and Head |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
| Address |
Department of Obstetrics and Gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9506898204 |
| Fax |
|
| Email |
jaya_sunil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Jaya Chaturwedi |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
| Address |
Department of Obstetrics and Gynaecology,AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9506898204 |
| Fax |
|
| Email |
jaya_sunil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences, Rishikesh |
| NIL |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences Rishikesh |
| Address |
All India institute of medical sciences, Rishikesh, Veerbhadra Marg, Pashulok, Rishikesh-Uttarakhand-249201 |
| 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 |
| Prof Jaya Chaturwedi |
All India institute of medical sciences, Rishikesh |
Department of Obstetrics and Gynaecology,
Dehradun
UTTARANCHAL |
8171025511
jaya_sunil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
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 |
| Comparator Agent |
Multiple peritoneal biopsies |
Multiple peritoneal biopsies from bilateral sub diaphragmatic area, parabolic gutters and pelvic peritoneum |
| Intervention |
Total parietal peritonectomy |
Total parietal peritonectomy including pelvic, diaphragmatic and parabolic peritonectomy in the absence of visible peritoneal disease |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Histologically proven epithelial ovarian cancer
2. undergoing interval cytoreduction surgery
3. post platinum based neoadjuvant chemotherapy |
|
| ExclusionCriteria |
| Details |
1. Women with non epithelial ovarian cancer
2. Women with visible peritoneal disease
3. Patients with progressive disease after neoadjuvant chemotherapy
4. Patients undergoing primary cytoreductive surgery
5. Patients with poor performance status, ECOG more than 3
6.Patients not consenting for the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage prevalence of occult tumour in peritoneal specimens |
At baseline Immediately post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative adverse events graded according to Common terminology criteria for adverse events CTCAE 5.0 (Annexure 7).
2. Postoperative adverse events (within 30 days) according to Clavien Dindo classification (Annexure 8).
3. 90 day morbidity & mortality rate .
4. Quality of life as determined by WHO QOL questionnaire.(Annexure 6)
5. Duration of surgery in minutes.
6. Amount of blood loss in ml.
7. Intraoperative Sugarbaker’s peritoneal carcinomatosis index score.(Annexure 2)
8. Duration of hospital stay in days.
9. Time to initiation of Chemotherapy postoperatively in days.
10. Chemotherapy response score on the basis of histopathological report.
11. Preoperative, post neoadjuvant chemotherapy & post surgery Ca-125 (u/ml) values in both groups.
|
1. At baseline
2. Within 30 days of surgery.
3. Within 90 days
4. At baseline & 8 weeks
5. At baseline
6. At baseline
7. At baseline
8. At baseline
9. At baseline.
10. At baseline
11. At baseline.
|
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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 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
|
This is an Exploratory randomised control trial. aimed at comparing the different peritonectomy techniques in detection of occult peritoneal disease in Interval cytoredcutive surgery for advanced ovarian cancer
Background-The goal of iCRS is to obtain a complete gross resection or complete cytoreduction (CC-0 resection) which is achieved by resecting sites of visible residual disease. This includes total hysterectomy with bilateral salpingo oophorectomy, pelvic and/or para aortic lymphadenectomy, supracolic omentectomy, peritoneal resection and visceral resections wherever necessary. In advanced ovarian cancer, after first line treatment, approximately 10% of the patients will never develop a recurrence. For the remaining 90%, the disease will invariably recur, with the peritoneum being the only or one of the sites of recurrence in more than 80% of the patients.In stages III-C and IV, the diaphragmatic peritoneum is invariably involved. It has been shown that despite having a normal appearance after NACT, microscopic residual disease is present in 15%–35% of the patients Purpose-The present study aims to analyse the role of extent of parietal peritonectomy on detection of occult peritoneal metastatic disease, morbidity and rate of recurrence in women undergoing interval cytoreductive surgery for advanced epithelial ovarian cancers The rationale behind the study is to detect presence of occult disease in normal looking peritoneum so that adjuvant treatment can be planned accordingly. Also the percentage of occult disease detection will be compared in the arms i.e total vs involved field parietal peritonectomy versus multiple peritoneal biopsies in order to counterweigh occult disease detection versus increased surgical morbidity.
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