Cytoreductive surgery and heated intraperitoneal chemotherapy in relapsed epithelial ovarian cancer – Randomised control trial

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/059184
• Lead Sponsor: BR Ambedkar Institute Rotary Cancer Hospital BRAIRCH

Brief Summary

The most common type of ovarian cancer is epithelial ovarian cancer (EOC) worldwide. The current standard treatment consists of complete Cytoreductive surgery with platinum-based chemotherapy (intravenous and intraperitoneal). Hyperthermic intraperitoneal chemotherapy (HIPEC) delivers heated chemotherapy drugs into the peritoneal cavity after the complete removal of the tumor (i.e. cytoreduction). HIPEC has become the advanced treatment modality for peritoneal surface malignancy like ovarian cancer, with a survival benefit noted in primary and recurrent tumors. Recently, response to HIPEC has been evaluated among different genomic profiles and patients with HRD tumors without pathogenic BRCA1/2 mutation appear to benefit most. In the recurrent disease, secondary CRS and HIPEC have emerged as promising treatment options  to improve outcomes. There is still some controversy regarding their efficacy, safety, and patient selection criteria.

Our study aims to evaluate the role of HIPEC in secondary CRS in recurrent epithelial ovarian cancers in terms of treatment response and to evaluate effect of HIPEC in HRD/BRCAwt genomic profile in these patients. The findings of this study could potentially inform clinical practice and contribute to the development of evidence-based guidelines for the management of recurrent epithelial ovarian cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-11
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 1.Patients with recurrent epithelial ovarian cancer 2.Biochemical, radiological or clinical recurrence 3.Patients satisfying the selection criteria score of >6 taking into account the parameters mentioned in the following table.
• ComponentsScore Performance status03 12 Optimized 21 >20 CT PCI≤83 9-122 13-151 ≥160 Progression free Interval>18 mo3 12-18 mo2 6-12 mo1 <6 mo0 Prior optimal CRSCC-03 CC-12 CC-21 CC-30 CA 125 at relapseNormal1 Elevated0 Symptomatic statusAsymptomatic1 Symptomatic0 Total14.

Exclusion Criteria

• 1.Platinum resistant disease 2.Patients who have received chemotherapy after detection of recurrence 3.
• Extraabdominal recurrent disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC	To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC

Secondary Outcome Measures

Name	Time	Method
1.To compare overall survival in two arms	2.To compare duration of hospital stay post operatively in two arms

Trial Locations

Locations (1)

AIIMS, Delhi; 🇮🇳 South, DELHI, India

AIIMS, Delhi

🇮🇳South, DELHI, India

Dr Divyam Goel

Principal investigator

8586015266

divyamgo@gmail.com