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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
KELIM
Diagnostic test(i) Patients with KELIM \>=1 will receive radiological assessment and undergo interval debulking surgery if the disease is operable. (ii) Patients with KELIM \<1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery
Carboplatin plus Paclitaxel
DrugChemotherapy as neaodjuvant chemotherapy
Interval debulking surgery
Procedure/SurgeryInterval debulking surgery
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Personalised managementExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Complete resection (CC0) rate
The likelihood of CC0 in patients who undergo IDS when KELIM reaches 1 or above
Time frame
Up to 24 months2
Sensitivity of KELIM in predicting CC0
The sensitivity of KELIM in predicting CC0
Time frame
Up to 24 weeksSecondary outcomes
1
Time required to achieve KELIM >=1
The time required for KELIM to reach \>=1 in EOC patients receiving NACT
Time frame
Up to 24 weeks2
Complication rates of treatment
The complication rates of surgery based on the Clavien-Dindo classification and chemotherapy based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame
Up to 1 year3
Quality-of-life scale
Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.
Time frame
Up to 1 yearOther outcomes
1
Expression of biomarkers
Expression levels of biomarkers before and after chemotherapy
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov