EUCTR2007-001152-39-NO招募中1 期
SSGXXA Scandinavian Sarcoma Group treatment protocol for adult patients with non-metastatic high-risk soft tissue sarcoma of the extremities and trunk wall
Scandinavian Sarcoma Group0 个研究点目标入组 180 人开始时间: 2007年4月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •a) Age = 18 years and <75 years
- •b) Performance status, WHO: 0 or 1(or higher if this is a consequence of sarcoma-related decreased motility)
- •c) White blood count = 3.0 x 109/l or neutrophiles =1.0 x 109/l and thrombocytes = 100 x 109/l
- •d) GFR = 70ml/min/1.73m2
- •e) ALAT and total bilirubin < 2 times normal upper limit
- •f) Adequate cardiac function (LVEF = 50%)
- •g) Extremity or trunk wall localization
- •h) Patients fulfilling the high-risk criteria defined above, section 4.2.1 and 4.2.2.
- •i) All histiotypes except: extraskeletal osteosarcoma and chondrosarcoma, Ewing, PNET, rhabdomyosarcoma, Kaposi`s sarcoma, malignant mesenchymoma, clear cell sarcoma, alveolar soft part sarcoma, epithelioid sarcoma
- •j) Not radiation induced sarcoma
- •k) No metastases diagnosed contemporary with the diagnosis of the primary tumor
- •l) At least 5 years free of another non-metastatic malignancy, except basal cell skin cancer or cervical carcinoma in situ
- •m) No previous anthracycline treatment
- •n) Not given any other treatment for this sarcoma including isolated limb perfusion with
- •TNF-alpha and melphalan (ILP)
- •o) Not pregnant or lactating
- •p) Time frames:
- •Group A(operated initially): Not more than 12 weeks (84 days) between final surgery and start of chemotherapy. Not more than 3 weeks (21 days) between registration and start of chemotherapy. Note that no chemotherapy may be given before registration!
- •Group B(not operated initially): Not more than 4 weeks (28 days) from diagnostic biopsy to start of chemotherapy subsequent to registration. Not more than 3 weeks (21 days) between registration and start of chemotherapy.
- •q) Written informed consent subsequent to given oral and written patient information
- •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
- •Not fulfilling the inclusion criteria above
研究者
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