Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

Sponsor
The University of Hong Kong
Study ID
NCT07022535
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KELIM — DIAGNOSTIC_TEST
    (i) Patients with KELIM \>=1 will receive radiological assessment and undergo interval 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
  • Carboplatin plus Paclitaxel — DRUG
    Chemotherapy as neaodjuvant chemotherapy
  • Interval debulking surgery — PROCEDURE
    Interval debulking surgery

Study Details

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.

Key Dates

First listed
Jun 15, 2025
Start date
May 28, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Personalised management
    Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.

Primary Outcome Measure

Complete resection (CC0) rate [ Time Frame: Up to 24 months ]

Central Contacts

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