Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

Sponsor
The University of Hong Kong
Study ID
NCT07023484
Phase
PHASE2
Status
Recruiting
Apply to this trial

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 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
  • Carboplatin plus Paclitaxel — DRUG
    Neoadjuvant 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 and compare this with the standard clinical practice.

Key Dates

First listed
Jun 17, 2025
Start date
May 22, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard clinical practice
    Participants will follow the standard practice and receive 3-6 cycles of neoadjuvant chemotherapy, followed by radiological assessment and interval debulking surgery.
  • 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 weeks from randomisation ]

Central Contacts

Find similar trials

Nationwide
Ovarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials

Related Studies