EUCTR2006-002687-26-DK进行中（未招募）不适用
En fase I / II forsøg med intraperitoneal Paclitaxel og Carboplatin efter cytoreduktiv operation som behandling af Patienter med ovarie carcinoma med peritoneal carcinose eller primær peritoneal carcinomatose
Rigshospital, Finsencenter, Afsnit 39940 个研究点目标入组 50 人开始时间: 2006年8月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Histologisk eller cytologisk påvist serøs peritoneal carcinomatose
- •- Ingen systemiske metastaser
- •- Optimal debulking (residual disease <1cm)
- •- ECOG perfomance status =2
- •- Sufficient leverfunktion defineret ved:
- •-Total billerubin = UNL (øvre normalgrænse)
- •-ASAT/ALAT= 1.5 x UNL
- •-Basisk fosfatase = 2,5 x UNL
- •- Sufficient nyrefunktion defineret ved:
- •- GFR = 35 ml/min
- •- Sufficient knoglemarvsfunktion defineret ved:
- •- Hb = 9.0 g/l sv.t. 7.0 mmol/l (om nødvendigt efter transfusion)
- •- Leukocytter = 3.5 x 109/l
- •- Neutrofiltal = 1.5 x 109/l
- •- Thrombocyttal = 100 x 109/l
- •- Forventet levetid > 3 måneder
- •- Skriftligt informeret samtykke
- •- Alderen >18 år
- •- Kan imødekomme kravene til opfølgning
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patienter der tidligere har fået behandlingsregimer med kemoterapi grundet metastaserende sygdom.
- •- Insufficient leverfunktion defineret ved:
- •-Total bilirubin > UNL
- •-ASAT/ALAT > 1,5 x UNL samtidig med alkalisk fosfatase 2,5 x UNL
- •- Insufficient nyrefunktion defineret ved:
- •- GFR < 35 ml/min
- •- Tidligere alvorlige allergiske reaktioner (f. eks anafylaktisk chok).
- •- Samtidig anden alvorlig og/eller ledsagende medicinsk tilstand.
- •- Kronisk inflammatorisk tarmsygdom og/eller tarmobstruktion
- •- Neutrofile granulocytter <1,5 x 109
- •- Gravide eller ammende.
研究者
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