Cytoreductive surgery and HIPEC in relapsed epithelial ovarian cancer – a phase III randomised control trial and descriptive study to evaluate effect of HIP3C in HRD/BRCAwt genomic profile
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC
研究概览
简要总结
The most common type of ovarian cancer is epithelial ovarian cancer (EOC) worldwide. The current standard treatment consists of complete Cytoreductive surgery with platinum-based chemotherapy (intravenous and intraperitoneal). Hyperthermic intraperitoneal chemotherapy (HIPEC) delivers heated chemotherapy drugs into the peritoneal cavity after the complete removal of the tumor (i.e. cytoreduction). HIPEC has become the advanced treatment modality for peritoneal surface malignancy like ovarian cancer, with a survival benefit noted in primary and recurrent tumors. Recently, response to HIPEC has been evaluated among different genomic profiles and patients with HRD tumors without pathogenic BRCA1/2 mutation appear to benefit most. In the recurrent disease, secondary CRS and HIPEC have emerged as promising treatment options to improve outcomes. There is still some controversy regarding their efficacy, safety, and patient selection criteria.
Our study aims to evaluate the role of HIPEC in secondary CRS in recurrent epithelial ovarian cancers in terms of treatment response and to evaluate effect of HIPEC in HRD/BRCAwt genomic profile in these patients. The findings of this study could potentially inform clinical practice and contribute to the development of evidence-based guidelines for the management of recurrent epithelial ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients with recurrent epithelial ovarian cancer 2.Biochemical, radiological or clinical recurrence 3.Patients satisfying the selection criteria score of >6 taking into account the parameters mentioned in the following table.
- •ComponentsScore Performance status03 12 Optimized 21 >20 CT PCI≤83 9-122 13-151 ≥160 Progression free Interval>18 mo3 12-18 mo2 6-12 mo1 <6 mo0 Prior optimal CRSCC-03 CC-12 CC-21 CC-30 CA 125 at relapseNormal1 Elevated0 Symptomatic statusAsymptomatic1 Symptomatic0 Total14.
排除标准
- •1.Platinum resistant disease 2.Patients who have received chemotherapy after detection of recurrence
- •Extraabdominal recurrent disease.
结局指标
主要结局
To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC
时间窗: To compare peritoneal recurrence free survival between secondary CRS and CRS + HIPEC
次要结局
- 1.To compare overall survival in two arms(2.To compare duration of hospital stay post operatively in two arms)