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RECRUITING
NCT07023484
PHASE2

Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients and compare this with the standard clinical practice.

Official title: Personalized Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Multicenter Randomized Phase II Non-inferiority Trial (PRESELECT-I Trial)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-05-22

Completion Date

2028-12-31

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

KELIM

(i) Patients with KELIM =\>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. (ii) Patients with KELIM \<1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery

DRUG

Carboplatin plus Paclitaxel

Neoadjuvant chemotherapy

PROCEDURE

Interval debulking surgery

Interval debulking surgery

Locations (6)

Sun Yat-sen University Cancer Center

Guangzhou, China

The University of Hong Kong - Shenzhen Hospital

Shenzhen, China

Pamela Youde Nethersole Eastern HospitalPamela Y

Chai Wan, Hong Kong

Queen Mary Hospital, Department of Clinical Oncology

Hong Kong, Hong Kong

The University of Hong Kong, Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong

United Christian Hospital

Kwun Tong, Hong Kong