RecruitingPhase 2NCT07023484

Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

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)

Sponsor

The University of Hong Kong

Enrollment

126 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized approach to timing surgery for women with advanced ovarian cancer who are receiving chemotherapy before their operation, using CA125 blood levels to determine the ideal time to operate. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer (confirmed by biopsy) - Your cancer cannot be removed surgically right away, so chemotherapy is planned first - You have had CT scans of your chest, abdomen, and pelvis - You have an elevated CA125 blood level at the start - You are in good health overall (ECOG 0–1) - You are willing to have surgery and follow-up chemotherapy after **You may NOT be eligible if...** - Your cancer is immediately removable by surgery - You are not healthy enough for surgery - You are pregnant - You started chemotherapy at another center more than one cycle ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTKELIM

(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

DRUGCarboplatin plus Paclitaxel

Neoadjuvant chemotherapy

PROCEDUREInterval debulking surgery

Interval debulking surgery