NCT02328716Unknown3 期
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma : Randomized Clinical Trial.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- disease-free survival period
研究概览
简要总结
The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma.
- •Residual tumor < 2.5 mm after completion of cytoreductive surgery.
- •Aged < 75 years.
- •Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
- •Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm
- •Adequate renal function with creatinine ? 1.5 mg/ dl.
- •Adequate liver function with bilirubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L.
- •Optimal cardiopulmonary function.
- •In recurrences, disease-free interval > 6 months.
- •Voluntary and signed written informed consent.
排除标准
- •Extraperitoneal tumor disease.
- •Suboptimal debulking (residual tumor > 2.5 mm).
- •Previous history of other malignancies (excluding skin)
- •Intestinal obstruction at the time of evaluation.
- •Renal failure.
- •Heart failure.
- •Uncontrolled infection.
- •Pregnant or lactating patients.
- •In recurrences, disease-free interval < 6 months.
研究组 & 干预措施
Comparator
Active Comparator
Comparator
干预措施: Cytoreduction (Procedure)
Experimental
Experimental
Experimental
干预措施: Cytoreduction (Procedure)
Experimental
Experimental
Experimental
干预措施: Hipec with Cisplatin (Drug)
结局指标
主要结局
disease-free survival period
时间窗: Every 3 months up to 30 months
Every three months until recurrence of disease.
次要结局
- Evaluation of quality of life related to the procedure.(Every 3 months up to 30 months)
- Study of Ex vivo correlation.(4 days post surgery)
- Evaluation of overall survival.(Every 3 months up to 30 months)
- Study of morbidity.(Every 3 months up to 30 months)
研究者
研究点 (1)
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