EUCTR2004-000242-20-FI进行中（未招募）1 期
A randomised trial of the European and American Osteosarcoma Study group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy - EURAMOS 1
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SSG
- 入组人数
- 1,334
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
- All
入选标准
- •Eligible patients will be registered, then following assessment of histological response of primary tumor, may be eligible for randomisation.
- •Registration:
- •1. Histological evidence of high grade osteosarcoma of the extremity or axial skeleton including those arising as second malignancies
- •2. Resectable disease
- •3. Age =40 years at date of diagnostic biopsy
- •4. Registration within 30 days of diagnostic biopsy
- •5. Start chemotherapy within 30 days of diagnostic biopsy
- •6. Neutrophils = 1.5 x 109/L (or WBC = 3 x 109/L if neutrophils are not available) and platelet count = 100 x 109/L
- •7. Glomerular Filtration Rate =70 mL/min/1.73 m2
- •8. Serum bilirubin = 1.5 x ULN
- •9. Sufficient cardiac function to receive anthracyclines: SF = 28% or EF = 50%
- •10. Adequate performance status (Karnofsky score = 60 or WHO = 2 for patients (age = 16), Lansky score = 60 (age < 16).
- •11. Patient fit to undergo protocol treatment and follow-up
- •12. Written informed consent.
- •Randomization
- •1. Assessment of histological response in primary tumor within 35 days of definitive surgery
- •2. Exactly two courses of cisplatin and doxorubicin must have been administered before surgery
- •3. At least two courses and no more than six courses of methotrexate must have been administered before surgery
- •4. Recovery from prior therapy allowing administration of chemotherapy
- •5. No progression of metastatic disease or new metastatic disease
- •6. Macroscopically complete surgical resection of the primary tumor
- •7. In patients with metastatic disease, complete removal of all metastases or complete removal planned and deemed feasible
- •8. Age = 5 for patients with good response
- •9. Written consent to undergo randomization.
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria are as follows: 1. Unresectable disease, primary or metastatic or both 2. Low grade osteosarcoma 3. Juxtacortical (periosteal, parosteal) osteosarcoma 4. Craniofacial osteosarcoma 5. Any previous treatment for osteosarcoma 6. Any previous chemotherapy for any disease 7. Any other medical condition precluding treatment with protocol chemotherapy (for example HIV, psychiatric disorder etc) 8. Pregnant or lactating women.
研究者
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