A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Event-free survival
研究概览
简要总结
The study is a first step of a process to establish the standard chemotherapy treatment with the aim to improve outcome for patients with these rare tumours. For this reason the study will be non-controlled clinical trial.
In this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.
详细描述
Wide surgical removal of the tumor with the addition of a systemic treatment based on the antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide, Methotrexate). The use of radiation therapy will be given to patients with unresectable tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor. The addition of radiation therapy can not compensate for an adequate surgical treatment.
All the patients eligible for the study will receive the planned systemic treatment. Depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 41 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of high-grade sarcoma of bone of any site.
- •Histologic types: osteosarcoma (high-grade surface, central primary and secondary), fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, angiosarcoma.
- •Age: 41 - 65
- •Normal bone marrow, hepatic, cardiac and renal function
- •Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide
- •Written informed consent
排除标准
- •Planned chemotherapy and/or follow-up not feasible
- •Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included in the present protocol
- •Previous chemotherapy treatment for the current tumor
- •White blood count < 3.0 x 109/L, and platelets < 100 x 109/L
- •Creatinine clearance < 70 ml/min
- •Left ventricular ejection fraction < 55% or fractional shortening rate of the left ventricle <28%
- •Serum transaminases and bilirubin > 2 times the normal values
- •ECOG performance status > 2
- •Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and Ewing's family tumors.
研究组 & 干预措施
Chemotherapy for Good responder
Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma
干预措施: Doxorubicin+cisplatin+ifosfamide (Drug)
Chemotherapy for Poor responder
Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma
干预措施: Doxorubicin+cisplatin+ifosfamide+methotrexate (Drug)
结局指标
主要结局
Event-free survival
时间窗: from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 168 months.
Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)
次要结局
- Disease-free survival(from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months)
- Progression-free survival(from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months)
- Chemotherapy toxicity(Every 3 weeks)
- Metastasis-free survival(from the date of randomization until the date of first documented progression in term of metastasis, whichever came first, assessed every 3 months, up to 168 months)
- Overall survival(from the date of randomization until the end of the study, assessed every 3 months, up to 168 month)