Personalized timing for interval debulking surgery in advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The University of Hong Kong, Department of Obstetrics and Gynaecology
  Hong Kong, Hong Kong Recruiting
• 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
• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.