Timing of surgery after chemotherapy for advanced ovarian cancer, guided by KELIM test
Tests a KELIM test to time surgery after chemotherapy in advanced ovarian cancer.
Plain-language title generated from the registry record
Registry title: Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Key facts
- Where
- Chai Wan, Hong Kong, and Kwun Tong, Hong KongSee the 4 sites
- Phase
- Phase 2
Where in Hong Kong
- Pamela Youde Nethersole Eastern HospitalPamela YChai Wan, Hong KongNot yet recruiting
- Queen Mary Hospital, Department of Clinical OncologyHong Kong, Hong KongNot yet recruiting
- The University of Hong Kong, Department of Obstetrics and GynaecologyHong Kong, Hong KongTaking people
- United Christian HospitalKwun Tong, Hong KongNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Hong Kong
- Trial code
- NCT07023484
- Record updated
- 2 July 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Patients aged 18 years old or older; Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment; Patients who can sign the informed consent; Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS; Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis; Patients who are planned for neoadjuvant chemotherapy (NACT) using 3-weekly carboplatin and paclitaxel. Those who have received one cycle of NACT may be eligible if the CA125 schedule of the study group can be matched; Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal); Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT; Patients with adequate hematologic, liver and renal functions for chemotherapy; Patients who agree to receive adjuvant chemotherapy after IDS. The total number of NACT and adjuvant chemotherapy should be four or above, up to maximum of 9 cycles; Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment; Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test.
Exclusion: Patients who are eligible for primary debulking surgery (PDS); Patients who have already started NACT outside the study centers, except those who have received only one cycle within 7 days and the baseline CA125 value within 3 days of NACT (normal cut-off 35 U/ml) is available; Patients who have contraindications to platinum-based chemotherapy; Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins; Patients with history of other malignancies within five years; Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded; Patients with mucinous and neuroendocrine histology; Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone; Patients who are not fit for PDS because of medical morbidities or refusal of operation; Patients who participate in other interventional studies; Patients who are pregnant or breastfeeding.