EUCTR2011-001715-31-ES进行中（未招募）1 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. - CarcinoHIPEC
Fundación para la Formación e Investigación Sanitaria de la Región de Murcia0 个研究点目标入组 126 人开始时间: 2011年9月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
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/mm3.
- •- Adequate renal function with creatinine ? 1.5 mg/ dl.
- •- Adequate liver function with bilitubin 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 infromed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
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.
- •- Hypersensitivity to cispñatin previously.
- •- Have been subjected to a procedure previously HIPEC.
- •- Denial of diseased part of the study.
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