Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- proportion of patients having an isolated and operable pulmonary relapse
研究概览
简要总结
Cancer surveillance has a significant cost and generate anxiety for the patient.
It is important to avoid exams that will not modify health support or whose results wont allow to decide.
详细描述
Cancer surveillance has a significant cost and generate anxiety for the patient.
It is important to avoid exams that will not modify health support or whose results wont allow to decide.
Our study will help rationalise surveillance of soft tissue sarcoma and standardize medical practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •soft tissue sarcoma, histologically proven
- •tumor size > 5 cm (SBR grade 2) or whatever size (SBR grade 3)
- •complete excision (R0 or R1)
- •no metastasis (checked by spiral chest CT)
- •social security covered
- •informed signed consent
排除标准
- •bone, visceral, uterine, retroperitoneal sarcoma
- •other malignant tumor
- •patients over 70, or for whom thoracic surgery is excluded
- •pneumoconiosis or known system disease
- •breast feeding or pregnant woman
- •patient unable to undergo trail medical follow up for geographic, social or psychological reasons
研究组 & 干预措施
chest radiography
clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year
干预措施: chest radiography (Procedure)
chest CT
clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year
干预措施: chest CT (Procedure)
结局指标
主要结局
proportion of patients having an isolated and operable pulmonary relapse
时间窗: 2 years
% of patients having resectable or resected lung metastasis after 2 years of surveillance
次要结局
- evaluate overall survival(5 years)
- estimate false positive rate(2 years)
- evaluate irradiation received(2 years)
- evaluate quality of life(every 3 months for 2 years then every 6 months for the 3rd year)
- evaluate free disease survival(5 years)
- evaluate global health(every 3 months for 2 years then every 6 months for the 3rd year)
- medico economic evaluation(5 years)