Personalized 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 and compare this with the standard clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years old or older
Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment
Patients who can sign the informed consent
Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS
Disqualifiers
Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins
Patients with mucinous and neuroendocrine histology
Patients with history of other malignancies within five years
Patients who are eligible for primary debulking surgery (PDS)
Trial design
Design model
Parallel
Treatments tested in this trial
KELIM
Diagnostic test(i) Patients with KELIM =\>1 will receive radiological assessment and undergo internal 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
DrugNeoadjuvant chemotherapy
Interval debulking surgery
Procedure/SurgeryInterval debulking surgery
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Standard clinical practiceActive comparator 2 interventions
Group B: 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
Time frame
up to 24 weeks from randomisation2
12-month progression-free survival (PFS) rate by RECIST criteria
PFS is defined as the time from the date of randomization until the date of progressive disease or death (whichever comes first).
Time frame
up to 24 months from randomisationSecondary outcomes
1
Chemotherapy response score (CRS)
CRS of omentum removed during interval debulking surgery CRS 1, there is no or minimal tumor response; CRS 2, there is appreciable tumor response amidst viable tumor; CRS 3, there is complete or near complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups or nodules up to 2 mm
Time frame
up to 24 weeks from randomisation2
Progression-free survival (PFS) by RECIST criteria
PFS is defined as the time from the date of randomization until the date of progressive disease or death (whichever comes first).
Time frame
up to 5 years from randomisation3
Overall survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Time frame
Up to 5 years from randomisation4
Incidence of adverse events
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 year from randomisationOther outcomes
1
Expression of biomarkers
Expression levels of biomarkers before and after chemotherapy
Time frame
up to 1 year from randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
United Christian Hospital
Collaborator
Pamela Youde Nethersole Eastern Hospital
Collaborator
The University of Hong Kong-Shenzhen Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Source ClinicalTrials.gov