Personalized timing for 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)
This study will test whether timing interval debulking surgery based on the CA125 drop (KELIM) after neoadjuvant chemotherapy helps people with advanced ovarian, fallopian tube, or primary peritoneal cancer have better surgical outcomes than usual care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 6 sites (Guangzhou and 5 other locations) |
| Trial ID | NCT07023484 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 2 interventional trial enrolls patients with stage III–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who are planned for neoadjuvant carboplatin plus paclitaxel because primary optimal debulking is not feasible. Participants are randomized to standard timing of interval debulking surgery or a KELIM-guided arm that adds a CA125 measurement at week 5 and calculates the CA-125 Elimination Rate Constant K (KELIM) via an online tool. Patients with KELIM ≥1 receive radiologic reassessment and proceed to interval debulking if operable, while those with KELIM <1 are offered alternative management such as adding bevacizumab or switching to dose-dense chemotherapy and defer surgery. Outcomes compare surgical resectability and management decisions between the personalized-timing strategy and current practice.
Who should consider this trial
Good fit: Adults (≥18) with stage III–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer not amenable to primary debulking, ECOG 0–1, planned for 3-weekly carboplatin plus paclitaxel, with baseline CA125 at least 2× the upper limit of normal, and able to consent.
Not a fit: Patients with early-stage disease, those already suitable for primary debulking, patients without elevated CA125, those with poor organ function or ECOG >1, or those unable/unwilling to attend participating centers are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, using CA125 kinetics to time surgery could increase the chances of optimal tumor removal and spare patients from premature or futile operations.
How similar studies have performed: Previous studies have shown CA125 kinetics and KELIM correlate with chemotherapy response and resectability, but applying KELIM to time interval debulking is a novel approach that has not yet been widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 years old or older 2. Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment 3. Patients who can sign the informed consent 4. Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS 5. Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis. 6. 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. 7. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal) 8. Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT 9. Patients with adequate hematologic, liver and renal functions for chemotherapy 10. 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. 11. Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment. 12. Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test. Exclusion Criteria: 1. Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins 2. Patients with mucinous and neuroendocrine histology 3. Patients with history of other malignancies within five years 4. Patients who are eligible for primary debulking surgery (PDS) 5. Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone 6. Patients who are not fit for PDS because of medical morbidities or refusal of operation 7. 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 8. Patients who participate in other interventional studies 9. Patients who are pregnant or breastfeeding 10. Patients who have contraindications to platinum-based chemotherapy 11. Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
Where this trial is running
Guangzhou and 5 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, China (Not_yet_recruiting)
- The University of Hong Kong - Shenzhen Hospital — Shenzhen, China (Not_yet_recruiting)
- Pamela Youde Nethersole Eastern HospitalPamela Y — Chai Wan, Hong Kong (Not_yet_recruiting)
- Queen Mary Hospital, Department of Clinical Oncology — Hong Kong, Hong Kong (Not_yet_recruiting)
- The University of Hong Kong, Department of Obstetrics and Gynaecology — Hong Kong, Hong Kong (Recruiting)
- United Christian Hospital — Kwun Tong, Hong Kong (Not_yet_recruiting)
Study contacts
- Principal investigator: Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG — The University of Hong Kong
- Study coordinator: Lesley Lau, MPhil
- Email: lsk382@hku.hk
- Phone: +852 22554265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.