Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intratumoral platinum (Pt) concentration at the end of perfusion after 90 minutes (in ng/mg wet tissue)
研究概览
简要总结
Cytoreductive surgery (CRS) with the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) is used in current clinical practice in selected patients with advanced ovarian cancer. Clinical evidence for the benefit of HIPEC in ovarian cancer comes from the pivotal phase 3 OVHIPEC trial. Worldwide, two established strategies exist for dosing of HIPEC protocols, which follow either a body surface area (BSA)-based or a concentration-based approach. Since both strategies result in different exposure to intra-peritoneal chemotherapy, we aim to compare the pharmacokinetics and safety of both strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •signed and written informed consent
- •age ≥ 18 years
- •patients eligible for interval cytoreductive surgery
- •histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer
- •when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, PAX8
- •neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel
- •following 2 cycles of chemotherapy no progression should occur
- •treated with optimal or complete interval cytoreductive surgery
- •fit for major surgery, WHO performance status 0-2
- •adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)
- •adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal)
- •adequate renal function (creatinine clearance ≥ 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI)
- •able to understand the patient information
排除标准
- •history of previous malignancy treated with chemotherapy
- •opting for fertility-sparing surgery
研究组 & 干预措施
Arm A
Patients in Arm A are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cispaltin-based HIPEC with a dosage of 100 mg/m2
干预措施: Cisplatin 100 mg/m2 (Drug)
Arm B
Patients in Arm B are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cisplatin- based HIPEC with a dosage of 40 mg/L perfusate.
干预措施: Cisplatin 40 mg/l (Drug)
结局指标
主要结局
Intratumoral platinum (Pt) concentration at the end of perfusion after 90 minutes (in ng/mg wet tissue)
时间窗: End of perfusion after 90 minutes
次要结局
- Toxicity evaluation (CTCAE 5.0)(The occurrence of adverse events will be monitored until 6 weeks after surgery)
- Platinum (Pt) concentration in normal tissue (in ng/mg wet tissue)(End of perfusion)
- Platinum (Pt) concentration in tumor tissue after 30 minutes and 60 minutes of perfusion (in ng/mg wet tissue)(After 30 minutes and 60 minutes of perfusion)
- Concentration versus time curve and area-under-the-curve (AUC) of intra-peritoneal Platinum (Pt) during perfusion(During perfusion)
- Maximum Concentration (Cmax) Platinum (Pt) in perfusate during perfusion(During perfusion)
- Time to Maximum Concentration (Tmax) Platinum (Pt) in perfusate during perfusion(During perfusion)
- Terminal elimination half-life (t1/2) Platinum (Pt) in perfusate during perfusion(During perfusion)
- Clearance from perfusate at the end of perfusion(End of perfusion)
- Overall Survival (OS)(Will be evaluated after 3 and 5 years after the last patient last visit)