Comparative analysis of normothermic intraperitoneal chemotherapy in primary cytoreductive surgery for advanced epithelial ovarian cancer- A Pilot study
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1)Intraoperative adverse events graded according to Common terminology criteria for adverse events CTCAE 5.0.
概览
简要总结
The trial is a randomised open label pilot exploratory study on comparative analysis of intraperitoneal administration of normothermic chemotherapy primary cytoreductive surgery in patients with advanced ovarian malignancy. Primary outcome is to compare intraoperative and postoperative events in both the arms. Secondary obejctives are to compare the recurrent rates and the time to subsequent adjuvant treatment and quality of life in both the arms. Study is based on the hypothesis that morbidity and complication rates are not increased with improvement in recurrence rates with the addition of a single sitting of normothermic intraperitoneal chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Epithelial ovarian or fallopian tube or primary peritoneal cancer FIGO 2023 stage III to IVA clinically or radiologically 2)Optimum cytoreduction i.e. R0 or R1(no macroscopic disease visible) achievable during upfront cytoreduction 3)Good performance score, ECOG 2 or less.
排除标准
- •Non epithelial cancer or borderline ovarian cancer 2)FIGO 2023 Stage I or II or IVB of epithelial ovarian, fallopian tube or primary peritoneal cancer 3)Serious intercurrent illness or medical condition 4)No prior diagnosis or treatment of any other cancer within last five years 5) ECOG 3 or more 6) Diffuse infiltration of stomach, dueodenum, head or middle of pancrease 7)Involvement of celiac trunk, hepatic arteries, left gastric artery, liver hilum, lung parenchyma metastasis, unresectable lymph nodes or brain metastasis.
结局指标
主要结局
1)Intraoperative adverse events graded according to Common terminology criteria for adverse events CTCAE 5.0.
时间窗: 30 days, 60 days, 6 months and 12 months from the date of surgery
2)Postoperative adverse events (within 30 days) according to Clavien Dindo classification
时间窗: 30 days, 60 days, 6 months and 12 months from the date of surgery
3)Duration of hospital stay in days
时间窗: 30 days, 60 days, 6 months and 12 months from the date of surgery
4)Preoperative and post-surgery CA-125(U/ml) values after four weeks in both groups.
时间窗: 30 days, 60 days, 6 months and 12 months from the date of surgery
次要结局
- 1. To calculate the delay in days from the day of surgery until 1st cycle of adjuvant intravenous chemotherapy(2. To calculate the disease recurrence rate from the time of surgery up to 12 months during follow-up)
研究者
Dr Devika J Kamat
AIIMS Rishikesh