Clinical trial · Interventional
Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin plus Paclitaxel | Drug | — | UNRESOLVED |
| Interval debulking surgery | Procedure | — | UNRESOLVED |
| KELIM | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Personalised management
- description
- Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.
- interventionNames
- Diagnostic Test: KELIM
- Drug: Carboplatin plus Paclitaxel
- Procedure: Interval debulking surgery
Primary outcomes (2)
- measure
- Complete resection (CC0) rate
- timeFrame
- Up to 24 months
- description
- The likelihood of CC0 in patients who undergo IDS when KELIM reaches 1 or above
- measure
- Sensitivity of KELIM in predicting CC0
- timeFrame
- Up to 24 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available