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临床试验/DRKS00008552
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

发起方
niversitätsklinikum für Strahlentherapie

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