CTRI/2026/02/104157尚未招募不适用
Feasibility and Safety of Intraoperative Normothermic Intraperitoneal Chemotherapy (NIPEC) following optimal cytoreduction in women with high grade serous epithelial ovarian cancer undergoing interval cytoreductive surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Conducting this study is essential to determine whether intraoperative NIPEC can provide a safe and practical intraperitoneal therapy alternative, complement systemic treatment, and potentially improve oncologic outcomes without imposing additional surgical morbidity. Establishing its safety and feasibility is the critical first step before larger trials can evaluate its long-term survival impact, making this investigation both timely and clinically relevant. In the Indian scenario, most patients belong to low socioeconomic class not affordable for HIPEC. In low cost we can provide almost equal results with low morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients with advanced high grade serous epithelial carcinoma ovary (Stage III-IV), fallopian tube carcinoma or primary peritoneal cancer with CC0/CC1 resection at the time of interval CRS
- •Age: 18-70 years.
- •ECOG performance status 0-
- •Adequate organ function with the following criteria: White blood cell (WBC) more than or equal to 4000/ul; Absolute Neutrophil Count (ANC) more than or equal to1500/ul; Platelet count more than or equal to 100×103/ul; AST less than or equal to 100 IU/L; (ALT) less than or equal to100 IU/L; Serum total bilirubin less than or equal to 1.5 mg/dL.
- •Serum Creatinine less than 1.2 mg/dl.
排除标准
- •1.Suboptimal debulking 2.Presence of extra abdominal disease at response assessment precluding complete cytoreduction 3.If Bevacizumab was given during NACT
- •Failure to give consent 5.Non-epithelial or type 1 EOC 6.Pre-existing renal or liver disease 7.Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation 8.Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease).
研究者
Dr Jyothivishnu J L
AIIMS, New Delhi
研究点 (1)
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