Intraperitoneal Chemotherapy Versus Triweekly Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Triweekly Chemotherapy With Bevacizumab Versus Intraperitoneal Chemotherapy as Frontline Therapy in Advanced Ovarian Cancer

Conditions
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Intraperitoneal Chemotherapy, Bevacizumab, Ovarian Cancer

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer who received debulking surgery, followed by either triweekly intravenous chemotherapy with bevacizumab or intraperitoneal chemotherapy; women who received neoadjuvant chemotherapy followed by interval debulking surgery were also eligible for participation. Intraperitoneal chemotherapy was defined as having one or more cycles of an intraperitoneal regimen administered. Exclusion Criteria: women who quit half-way or received chemotherapy at other site

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraperitoneal group<br>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. | Drug: Chemotherapy<br>* Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab<br>|
| Triweekly group<br>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]. | Drug: Chemotherapy<br>* Triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy without bevacizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |