Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• Patients must be at least 18 years old.

• Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.

• Patients who are competent to give informed consent.

• Patients who have stage III-IV histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer not amenable for primary debulking surgery (PDS).

• Patients who are planned for neoadjuvant chemotherapy (NACT) using platinum-based chemotherapy +/- bevacizumab or biosimilar. Those who are receiving NACT before interval debulking surgery (IDS) are also eligible.

• Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).

• Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS.

• Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.

• Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.

Locations
Other Locations
Hong Kong Special Administrative Region
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Lesley Lau, MPhil
lsk382@hku.hk
+852 22554265
Backup
Iris Tang
iristwk@hku.hk
+852 22554265
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 18
Treatments
Experimental: Personalised management
Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov

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