Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
Qualifiers
Patients must be at least 18 years old.
Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.
Patients who are competent to give informed consent.
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).
Disqualifiers
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
Patients who are eligible for PDS
Patients who are not fit for PDS because of medical morbidities or refusal of operation
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.
Trial design
Treatments tested in this trial
- KELIM
- Carboplatin plus Paclitaxel
- Interval debulking surgery
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov