Surgical and survival outcomes of patients undergoing CRS +HIPEC with Cisplatin for advanced ovarian cancer in a tertiary care hospital in India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS Bhopal
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1.To estimate the incidence of post-surgical complication rate (at 30 days) using the Clavien-Dindo Grading system.
研究概览
简要总结
Ovarian cancer is 3rd most common cancer among females in India (over all 9th common) with 5-year prevalence of 17.6/ 1lakh population. It is a silent cancer with less or no symptoms in early stages and most of the patients presenting at advanced stages of disease. Data from hospital-based cancer registries published in 2022, showed almost 41.9% cases presented in locally advanced stage, 29% with distant metastasis and only 29% (less than 1/3rd) had localized disease. Even in case of localized disease, almost 80% of patient will have persistent disease or recurrence. Currently combined treatment with both cytoreductive surgery(CRS) and chemotherapy remains main stay of treatment. Intraperitoneal chemotherapy was advocated as high doses of chemotherapeutic drugs can be administered in peritoneal cavity without much increase in plasma concentration levels as shown in studies conducted by Dedrick et al. Studies have shown intraperitoneal chemotherapy to be improving survival outcomes. But was associated with peritoneal catheter related complications and sepsis leading to delay and discontinuation of chemotherapy. Sugar baker et al also showed administration of chemotherapy with intraperitoneal catheters had incomplete coverage of peritoneal surface, leading to decreased efficacy. To bypass these difficulties intraoperative intraperitoneal chemotherapy was proposed just after cytoreduction under hyperthermic conditions and was found to be have added survival benefits among patients compared to patients receiving only cytoreductive surgery alone. Most of the data in this topic is from western countries and data from Indian population is limited. This current study aims to study the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) when combined with CRS in Indian population and early postoperative morbidity and mortality associated with it and quality of life of patients undergoing HIPEC, compared to CRS alone.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients Aging from 18 to 75 years of age 2)ECOG score less than or equal to 1 3)Primary or recurrent epithelial ovarian cancer 4)Partial or complete Response to perioperative chemotherapy if given (biochemical and imaging) Imaging by RECIST 1.1 criteria 27 Biochemical by ca125 levels as defined by gynecologic cancer intergroup (GCIG).
- •best combined overall response as given by GCIG will be used 5)Cc score 0/1.
排除标准
- •Stage 4 ovarian cancers 2)Progressive on chemotherapy (biochemical and imaging) 3)ECOG score more than
- •29 4)Non epithelial histology.
结局指标
主要结局
1.To estimate the incidence of post-surgical complication rate (at 30 days) using the Clavien-Dindo Grading system.
时间窗: 1. Incidence of post-surgical complication rate (at 30 days). | 2. Incidence of early mortality (at 30 days). | 3.survival outcomes at one year.
2. To estimate the incidence of early mortality (at 30 days).
时间窗: 1. Incidence of post-surgical complication rate (at 30 days). | 2. Incidence of early mortality (at 30 days). | 3.survival outcomes at one year.
3. To assess survival outcomes (eg. recurrence-free median survival duration, recurrence-free median survival rate, incidence density of recurrence, etc.) at one year.
时间窗: 1. Incidence of post-surgical complication rate (at 30 days). | 2. Incidence of early mortality (at 30 days). | 3.survival outcomes at one year.
次要结局
- To estimate the incidence of chemotoxicity (at 14 days) among participants who undergo HIPEC post-cytoreductive surgery for management of Ovarian cancer(at 14 days)
- 5. To determine the change in the health-related quality of life (QoL) among patients undergoing CRS + HIPEC between before surgery and at 6 months(before surgery)
研究者
Avinash Ramakrishnan
AIIMS, BHOPAL