NCT07023484RecruitingPhase 2
Personalized Timing of 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)
Source: ClinicalTrials.gov · Last updated 2 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 7 Jun 2025
- Start date
- 22 May 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- The University of Hong Kong
- Diseases
- Ovarian cancer
- NCT number
- NCT07023484
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 126
- From 22 May 2025 to the primary completion date, 31 Dec 2028
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The University of Hong Kong-Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| Pamela Youde Nethersole Eastern HospitalPamela Y Coordinator of this site? Confirm its status | Chai Wan | Hong Kong SAR China | Not yet recruiting |
| The University of Hong Kong, Department of Obstetrics and Gynaecology Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Queen Mary Hospital, Department of Clinical Oncology Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Not yet recruiting |
| United Christian Hospital Coordinator of this site? Confirm its status | Kwun Tong | Hong Kong SAR China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.