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The combination of paclitaxel and carboplatin is the standard first-line chemotherapy for ovarian cancer as recommended by the NCCN Guidelines for Epithelial Ovarian Cancer, and is conventionally given via intravenous route every three weeks. The addition of target therapy (bevacizumab) has shown to improve progression free survival but not overall survival. Several trials have also demonstrated a clinically significant survival advantage associated with intraperitoneal chemotherapy compared to intravenous chemotherapy, and the best outcomes are consistently seen for patients who have no residual disease. This study aims to compare triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal group | The intraperitoneal regimen was given as 135 mg/m2 intravenous paclitaxel over a 3 or 24 hours period on day 1, followed by 75-100 mg/m2 intraperitoneal cisplatin on day 2 and 60 mg/m2 intraperitoneal paclitaxel on day 8. For women with significantly impaired renal function (i.e., estimated glomerular filtration rate<50 mL/min/1.73 m2), carboplatin (area under the curve [AUC]=6) was used instead of cisplatin. |
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| Triweekly group | The triweekly intravenous chemotherapy regimen was given as 175 mg/m2 paclitaxel and carboplatin at a dose calculated to produce an AUC of 6 mg/mL/min on day 1. Bevacizumab was given at a dose of 7.5mg/kg intravenously on day 2 since cycle 2. The treatments were repeated every 3 weeks for 6 cycles. Those women without achievement of complete response after 6 cycles of chemotherapy might be treated with an additional 1-2 cycles of chemotherapy. Bevacizumab was continued for 12 additional cycles or until disease progression, death, unacceptable toxic effects, or patient voluntary withdrawal [5]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | the time interval from the date of surgery or neoadjuvant chemotherapy to clinically defined recurrence, disease progression, or the last follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the time interval from the date of surgery or neoadjuvant chemotherapy to the date of death from any cause or the last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer
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women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital | Banqiao District | New Taipei | 22050 | Taiwan |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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 |