Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Physical functioning assessment
研究概览
简要总结
In order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.
详细描述
This is a prospective cohort including 100 patients > 70 year-old treated by surgery for lower-limb soft-tissue sarcoma. Data on clinical and geriatric characteristics of the patient as well as functional and quality of life assessment will be collected among patient participation (3 years). Primary endpoint is to describe evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged more than 70 years,
- •Soft tissue sarcoma histologically proven,
- •Sarcoma of the soft tissues of the lower limbs,
- •Operable disease (first-line treatment or neo-adjuvant therapy),
- •ECOG, Performance Status ≤ 2,
- •Decision of surgery validated in Multidisciplinary Consultation Meeting,
- •Reports of the non-opposition documented in the patient file before any procedure specific to the study,
- •Affiliation to system of Social Security (accordance with article L1121-11 of the Code of Public Health).
排除标准
- •Metastatic disease from the onset or relapse
- •Participation in another study involving a similar geriatric assessment.
- •Geographic, familial, social, psychological or psychiatric factors that make the patient incapable of undergoing the study's follow-up and procedures.
- •Persons deprived of liberty or placed under judicial protection
研究组 & 干预措施
Prospective cohort
Geriatric assessment
干预措施: Geriatric assessment (Procedure)
结局指标
主要结局
Change in Physical functioning assessment
时间窗: Change from baseline until 36 months after surgery
Quality of life questionnaire QLQ-C30
次要结局
- Surgical complications(Change from Day 0 until 12 months after surgery)
- OS(Change from Day 0 until 36 months after surgery)
- Functional status assessment (MST)(Change from baseline until 36 months after surgery)
- Geriatric parameters assessment - G8(baseline)
- Functional status assessment (TESS)(Change from baseline until 36 months after surgery)
- Geriatric parameters assessment - ADL(Change from baseline until 36 months after surgery)
- Geriatric parameters assessment - IADL(Change from baseline until 36 months after surgery)
- Quality of life assessment QLQ-C30(Change from baseline until 36 months after surgery)
- Time until deterioration of physical functioning(Change until 36 months after surgery)
- Geriatric parameters assessment - MNA(Change from baseline until 36 months after surgery)
- Geriatric parameters assessment - GDS 15(Change from baseline until 36 months after surgery)
- Geriatric parameters assessment - MMSE(Change from baseline until 36 months after surgery)
- Pain Assessment(Change from Baseline until 36 months after surgery)
- Quality of life assessment QLQ-EDL-14(Change from baseline until 36 months after surgery)
- Geriatric parameters assessment - CIRS-G(baseline)