Total peritonectomy versus peritoneal biopsies in interval cytoreduction

Comparative analysis of peritonectomy techniques in detection of occult peritoneal disease in Interval cytoreductive surgery for advanced ovarian cancer (ToPIC)-An Exploratory randomised study - ToPIC

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090264

Enrollment

Registered

2025-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

Interventions

Intervention1: Total parietal peritonectomy: Total parietal peritonectomy including pelvic, diaphragmatic and parabolic peritonectomy in the absence of visible peritoneal disease Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven epithelial ovarian cancer 2. undergoing interval cytoreduction surgery 3. post platinum based neoadjuvant chemotherapy

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Percentage prevalence of occult tumour in peritoneal specimensTimepoint: At baseline Immediately post operative period	—

Secondary

Measure	Time frame
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. Timepoint: 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.	—

Measure

Time frame

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. Timepoint: 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.

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Countries

India

Contacts

Public ContactProf Jaya Chaturwedi

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH

jaya_sunil@yahoo.com9506898204

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026