跳至主要内容
临床试验/NCT05410938
NCT05410938已完成不适用

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

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2022年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Progression free survival

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • women who quit half-way or received chemotherapy at other site

研究组 & 干预措施

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.

干预措施: Chemotherapy (Drug)

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].

干预措施: Chemotherapy (Drug)

结局指标

主要结局

Progression free survival

时间窗: the time interval from the date of surgery or neoadjuvant chemotherapy to clinically defined recurrence, disease progression, or the last follow-up

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng-Mou Hsiao

Chief of Department of Obstetrics and Gynecology

Far Eastern Memorial Hospital

研究点 (1)

Loading locations...

相似试验