Personalized timing of interval debulking surgery for advanced ovarian, fallopian tube, and peritoneal cancer.
Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study
This study will see if using the CA125 drop rate (KELIM) to decide when to do interval debulking surgery helps people with advanced ovarian, fallopian tube, or peritoneal cancer who are receiving neoadjuvant chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07022535 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional study uses serial CA125 measurements early in treatment to calculate the CA125 ELIMination Rate Constant (KELIM). KELIM is used to classify patients as rapid or slow biochemical responders after starting platinum-based neoadjuvant chemotherapy. Patients with KELIM ≥ 1 will undergo radiologic reassessment and proceed to interval debulking surgery if the disease is operable, while patients with KELIM < 1 will receive alternative management such as adding bevacizumab or switching to dose-dense chemotherapy and have surgery deferred. The trial is run at the University of Hong Kong and focuses on tailoring surgery timing to individual chemo response.
Who should consider this trial
Good fit: Adults (≥18 years) with stage III–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer planned for neoadjuvant platinum-based chemotherapy, ECOG 0–1, able to consent, with baseline CA125 at least twice the upper limit of normal and baseline CT/PET-CT or MRI available, are ideal candidates.
Not a fit: Patients who are candidates for primary optimal debulking surgery, who have very low or non-evaluable CA125, or who are not fit for planned chemotherapy or further surgery are unlikely to gain benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could increase the chance of optimal tumor removal and avoid unnecessary or poorly timed surgeries by personalizing when interval debulking occurs.
How similar studies have performed: Previous research has shown CA125 kinetics and KELIM correlate with chemotherapy response and resectability, but using KELIM prospectively to time interval debulking surgery is a relatively novel strategy that is not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients must be at least 18 years old. 2. Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1. 3. Patients who are competent to give informed consent. 4. 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). 5. 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. 6. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal). 7. 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. 8. Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice. 9. Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above. Exclusion Criteria: 1. Patients who have borderline malignancy, or non-epithelial ovarian cancer like germ cell or sex cord tumor, or metastatic diseases from other origins like Krukenberg's tumor 2. Patients who are eligible for PDS 3. Patients who are not fit for PDS because of medical morbidities or refusal of operation 4. Patients who have already started NACT outside the study centres, except those who have just had one cycle within 21 days and the baseline CA125 is available. 5. Patients who are pregnant
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong (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.