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About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.
Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy and surgery arm | Experimental | Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin or cisplatin | Procedure | Carboplatin of cisplatin for 3-6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete resection rate | Rate of complete resection at the time of operation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month progression-free survival rate | The time from the first dose of chemotherapy to the first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first. | 12 months |
| 12-month overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lesley Lau | Contact | 852-22554265 | lsk382@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Ka Yu Tse | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery
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| Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar | Drug | Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles |
|
|
| Bevacizumab or biosimilar | Drug | Optional |
|
|
| Cytoreductive surgery | Procedure | Cytoreductive surgery after chemotherapy |
|
Overall survival is defined as the time from the first dose of chemotherapy to the date of death due to any cause.
| 12 months |
| Surgical complication rate | Complications are graded by the Clavien-Dindo classification | 12 months |
| 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. | 12 months |
| ID | Term |
|---|---|
| D010051 | Ovarian 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D000093542 | Gemcitabine |
| C506643 | liposomal doxorubicin |
| D000068258 | Bevacizumab |
| D059451 | Biosimilar Pharmaceuticals |
| D065426 | Cytoreduction Surgical Procedures |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D013514 | Surgical Procedures, Operative |
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