Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Recurrent Ovarian Carcinoma
• Interventions: Procedure: Carboplatin or cisplatin; Drug: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar; Drug: Bevacizumab or biosimilar; Procedure: Cytoreductive surgery

• Registration Number: NCT06292286
• Lead Sponsor: The University of Hong Kong

Brief Summary

About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.

Detailed Description

Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-12-15
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
• >= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
• Platinum-free interval should be >=6 months from the last dose of platinum-based chemotherapy
• Upfront SCR not feasible
• Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
• Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.

Exclusion Criteria

• Non-epithelial or borderline tumors are excluded
• Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded.
• Patients using more than one line of chemotherapy are excluded.
• Patients who have platinum-resistant or refractory recurrence are excluded.
• Patients having second relapse or beyond are excluded.
• Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy and surgery arm	Cytoreductive surgery	Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
Chemotherapy and surgery arm	Bevacizumab or biosimilar	Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
Chemotherapy and surgery arm	Carboplatin or cisplatin	Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
Chemotherapy and surgery arm	Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar	Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.

Primary Outcome Measures

Name	Time	Method
Complete resection rate	12 months	Rate of complete resection at the time of operation

Secondary Outcome Measures

Name	Time	Method
12-month progression-free survival rate	12 months	The time from the first dose of chemotherapy to the first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.
12-month overall survival rate	12 months	Overall survival is defined as the time from the first dose of chemotherapy to the date of death due to any cause.
Quality of life scale	12 months	Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.
Surgical complication rate	12 months	Complications are graded by the Clavien-Dindo classification

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong