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

Cytoreductive surgery and HIPEC in relapsed epithelial ovarian cancer – a phase III randomised control trial and descriptive study to evaluate effect of HIP3C in HRD/BRCAwt genomic profile - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059184

Enrollment

Registered

2023-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: HIPEC: HIPEC - heated intraperitoneal chemotherapy is given intraoperatively after completion of cytoreductive surgery Dose - cisplatin at 70mg/sqm, frequency- single time administratio

Eligibility

Inclusion criteria

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. Components Score Performance status 0 3 1 2 Optimized 2 1 >2 0 CT PCI =8 3 9-12 2 13-15 1 =16 0 Progression free Interval >18 mo 3 12-18 mo 2 6-12 mo 1 Prior optimal CRS CC-0 3 CC-1 2 CC-2 1 CC-3 0 CA 125 at relapse Normal 1 Elevated 0 Symptomatic status Asymptomatic 1 Symptomatic 0 Total 14

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPECTimepoint: To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC	—

Secondary

Measure	Time frame
1.To compare overall survival in two arms 2.To compare duration of hospital stay post operatively in two arms 3.To compare post operative complications in two armsTimepoint: 1.Overall survival 2.Duration of hospital stay post operatively 3.Post operative complications	—

Countries

India

Contacts

Public ContactDivyam Goel

Department of surgical oncology, AIIMS, Delhi

drmajormdrayaiimsdelhi@aiims.edu8586015266

Outcome results

None listed

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