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| ID | Type | Description | Link |
|---|---|---|---|
| HKUCTR-3091 | Registry Identifier | HKU Clinical Trials Registry |
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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.
Recruited patients will have additional CA125 at 4th (before administration of chemotherapy), and 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined. 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 |
|---|---|---|---|
| Personalised management | Experimental | Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resection (CC0) rate | The likelihood of CC0 in patients who undergo IDS when KELIM reaches 1 or above | Up to 24 months |
| Sensitivity of KELIM in predicting CC0 | The sensitivity of KELIM in predicting CC0 | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time required to achieve KELIM >=1 | The time required for KELIM to reach >=1 in EOC patients receiving NACT | Up to 24 weeks |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of biomarkers | Expression levels of biomarkers before and after chemotherapy | Up to 1 year |
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 |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
Patients' disease course based on this novel management algorithm
One year after the end of the study
The study protocol will be available under a reasonable request to the corresponding author
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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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D065426 | Cytoreduction Surgical Procedures |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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Pilot study, single-arm
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|
| Carboplatin plus Paclitaxel | Drug | Chemotherapy as neaodjuvant chemotherapy |
|
| Interval debulking surgery | Procedure | Interval debulking surgery |
|
|
| Up to 1 year |
| 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 |
| 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 |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013514 | Surgical Procedures, Operative |