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| ID | Type | Description | Link |
|---|---|---|---|
| HKUCTR-3092 | Registry Identifier | HKU Clinical Trials Registry |
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| Name | Class |
|---|---|
| Queen Mary Hospital, Hong Kong | OTHER |
| United Christian Hospital | OTHER |
| Pamela Youde Nethersole Eastern Hospital | OTHER |
| The University of Hong Kong-Shenzhen Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard clinical practice | Active Comparator | Participants will follow the standard practice and receive 3-6 cycles of neoadjuvant chemotherapy, followed by radiological assessment and interval debulking surgery. |
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| Personalised management | Experimental | Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resection (CC0) rate | The likelihood of CC0 in patients who undergo IDS when KELIM reaches >=1 | 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). | up to 24 months from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 24 weeks from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of biomarkers | Expression levels of biomarkers before and after chemotherapy | up to 1 year from randomisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lesley Lau, MPhil | Contact | +852 22554265 | lsk382@hku.hk | |
| Iris Tang | Contact | +852 22554265 | iristwk@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | China |
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| OTHER |
| Sun Yat-Sen University Cancer Center | OTHER |
non-inferiority randomised trial
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Completeness of resection is assessed by independent surgeon
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| Carboplatin plus Paclitaxel | Drug | Neoadjuvant chemotherapy |
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| Interval debulking surgery | Procedure | Interval debulking surgery |
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| 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). | 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. | 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) | 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. | up to 1 year from randomisation |
| The University of Hong Kong - Shenzhen Hospital | Not yet recruiting | Shenzhen | China |
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| Pamela Youde Nethersole Eastern HospitalPamela Y | Not yet recruiting | Chai Wan | Hong Kong |
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| Queen Mary Hospital, Department of Clinical Oncology | Not yet recruiting | Hong Kong | Hong Kong |
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| The University of Hong Kong, Department of Obstetrics and Gynaecology | Recruiting | Hong Kong | Hong Kong |
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| United Christian Hospital | Not yet recruiting | Kwun Tong | Hong Kong |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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