DRKS00008552招募中1 期
Phase I study for simultaneous radiochemotherapy of relapsed ovarian cancer - Ovaradrez
niversitätsklinikum für Strahlentherapie0 个研究点目标入组 6 人开始时间: 2015年5月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- Female
入选标准
- •1. patient with initial histologically confirmed, abdominally relapsed malignant serous, mucinous or endometrioid ovarian cancer, carcinoma of the tube, or primary peritoneal.
- •2. platinum-sensitive or platinum-refractory relapse into the peritoneal cavity and simultaneously in subdiaphragmal nearby lymph nodes
- •3. adequate renal function (calculated GFR> 60 mL / min acc. Cockcroft-Gault formula) and normal liver function (ALT, AST, bilirubin
- •4. Minimum age 18 years
排除标准
- •1. recurrence surgery promising or necessity of immediate surgery
- •2. Other malignant neoplasm in history except basal cell carcinoma
- •3. Karnofsky index below 40% (= disabled, skilled help needed)
- •4. contrast agent allergy
- •5. Participation in other clinical study
- •6. symptomatic adhesions after previous abdominal or pelvic surgery
- •7. pre-existing bowel disease
- •8. Clear cell tumor, germ cell tumor, yolk sac tumor or borderline tumor of the ovary
- •9. inability arms to store high
- •10. bone marrow dysfunction, thrombocytopenia, leukopenia
- •11 serious multimorbidity
- •12. bleeding
- •13.extraabdominelle distant metastases, liver metastases
- •14. relevant renal or hepatic impairment
- •15. application of bevacizumab in the past 4 weeks (because of the associated risk of bowel perforation)
研究者
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