Monocentric Randomized Study Evaluating the Impact of an Early Multidisciplinary Program in Elderly Subjects Starting a Chemotherapy for Digestive Cancer: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Impact of EPODIG-G program on treatment.
研究概览
简要总结
This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.
详细描述
At the ICANS an EPODIG-G program, consisting in a coordination of supportive care that are existing in the Institute, is proposed to elderly patients with digestive cancer. The purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (EPODIG-G), when it is initiated before therapeutic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 75 years old
- •Performance status 0, 1 or 2
- •Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy for a treatment period of 24 weeks or more
- •Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible
- •Estimated life expectancy ≥ 3 months
- •Patients able to speak, read and understand French
- •Signed informed consent from the patient
- •Patients must have a social security coverage
排除标准
- •History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine)
- •Cancer currently being treated (except for hormone therapy) other than current digestive cancer
- •History of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion
- •Patients unable to submit to medical follow-up for geographical, social or psychological reasons
- •Patients placed under guardianship
研究组 & 干预措施
Arm A Standard of care
Patients will receive standard care before treatment initiation (i.e. geriatric assessment only).
Geriatric assessment includes: Mini Mental State Examination ; mini-Geriatric Depression Scale (mini-GDS) ; Body Mass Index (BMI) calculation ; Mini Nutritional Assessment (MNA) ; Time up and Go ; Cumulative Illness Rating Scale - Geriatric (CIRS-G) ; Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) questionnaires.
Arm B Multidisciplinary EPODIG program
Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation.
干预措施: EPODIG-G program (coordination of supportive care) (Other)
结局指标
主要结局
Impact of EPODIG-G program on treatment.
时间窗: 24 weeks after treatment initiation
Number of patients who benefit from all programmed treatment cycles at 24 weeks
次要结局
- Overall survival(3 years after last inclusion)
- Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.(24 weeks after treatment initiation)
- Number of adverse events and serious adverse events according to CTCAE v5.0.(throughout treatment, at 8, 16 and 24 weeks after treatment initiation)
- Progression free survival(3 years after last inclusion)