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.
Recruited patients will be randomised into two groups. The control group will receive treatment according to the standard clinical practice. The investigation group will have an additional CA125 at the 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined using online tool. Patients with KELIM =\>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
(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
Neoadjuvant chemotherapy
Interval debulking surgery
Sun Yat-sen University Cancer Center
Guangzhou, China
NOT_YET_RECRUITINGThe University of Hong Kong - Shenzhen Hospital
Shenzhen, China
NOT_YET_RECRUITINGPamela Youde Nethersole Eastern HospitalPamela Y
Chai Wan, Hong Kong
NOT_YET_RECRUITINGQueen Mary Hospital, Department of Clinical Oncology
Hong Kong, Hong Kong
NOT_YET_RECRUITINGThe University of Hong Kong, Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong
RECRUITINGUnited Christian Hospital
Kwun Tong, Hong Kong
NOT_YET_RECRUITINGComplete resection (CC0) rate
The likelihood of CC0 in patients who undergo IDS when KELIM reaches \>=1
Time frame: up to 24 weeks from randomisation
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 randomisation
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 randomisation
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 randomisation
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 randomisation
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 randomisation
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 year from randomisation
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