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临床试验/DRKS00000942
DRKS00000942已完成不适用

A European treatment protocol for bonesarcomain patients older than 40 years (EURO-B.O.S.S.) - Euro-B.O.S.S.

Klinikum Stuttgart0 个研究点目标入组 135 人开始时间: 2015年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
40 Years 至 65 Years(—)
性别
All

入选标准

  • 1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.
  • 2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary),
  • fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma,
  • angiosarcoma.
  • EUROpean Bone Over 40 Sarcoma Study EURO-B.O.S.S. Version_2.0 COSS Dec 2009 13/24
  • 3. Age: 41 - 65
  • 4. Normal bone marrow, hepatic, cardiac and renal function
  • 5. Absence of contraindications to the use of cisplatin, adriamycin (doxorubicin), and ifosfamide
  • 6. Written informed consent

排除标准

  • 1. Planned chemotherapy and/or follow-up not feasible
  • 2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included
  • in the present procol
  • 3. Previous chemotherapy treatment for the current tumor
  • 4. White blood count < 3.0 x 109/L, and platelets < 100 x 109/L
  • 5. Creatinine clearance < 70 ml/min
  • 6. Left ventricular ejection fraction < 55% or fractional shortening rate of the left ventricle <28%
  • 7. Serum transaminases and bilirubin > 2 times the normal values
  • 8. ECOG performance status > 2
  • 9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and
  • Ewing’s family tumors.
  • 10. Pregnancy

研究者

发起方
Klinikum Stuttgart

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