Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy. A Multicenter Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 48
- 主要终点
- Change in Patient-reported symptoms as measured by ESAS-r
研究概览
简要总结
The purpose of this study is to assess whether a structured physical activity program (PA) during palliative chemotherapy improves progression-free survival (PFS) and/or patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.
详细描述
While safety and feasibility as well as some improvements in fitness, fatigue and certain aspects of quality of life have been shown for physical activity in cancer patients during treatment, none of the pre-requisites above (i-iv) is fulfilled in the setting of patients with advanced colon cancer.
However, evidence, primarily from the adjuvant setting, that physical activity impacts on treatment tolerability and tumor progression is a strong enough rationale to now embark on this prospective trial. By assessing in a large randomized controlled trial whether a 12-week structured physical activity program during chemotherapy in patients with newly diagnosed colorectal cancer undergoing standard first-line chemotherapy improves progression-free survival as compared to standard first-line chemotherapy alone, all pre-requisites for a practice-changing intervention are met.
The physical exercise ACTIVE-program describes a 12-week exercise program consisting of a combination of a bi-weekly aerobic exercise (cycle ergometer) supervised by a physical therapist and a self-paced increase in physical activity during daily life using a pedometer with a daily step goal as a motivational tool.
In addition to the supervised exercise program twice a week, patients of the intervention group are recommended to be physically active at home.
All patients will undergo standard systemic therapy for metastatic colorectal cancer. Patients in the care-as-usual group are not actively encouraged to change their physical activity level e.g. to start a fitness program during chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent according to ICH/GCP regulations before randomization.
- •Patient with histologically or cytologically confirmed colorectal carcinoma (CRC) who start palliative first-line systemic therapy for inoperable or metastatic disease.
- •Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.
- •Patients with histologically or cytologically confirmed colorectal carcinoma (CRC), who start first-line "conversion"-therapy for borderline resectable metastatic disease and will be reassessed for metastasectomy after 3-4 months of systemic treatment.
- •Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.
- •Patients who are diagnosed with metastatic disease and were initially treated with surgery and/or radiochemotherapy to the primary tumor are eligible (except if all disease sites/metastases have been removed) Patients who have been curatively treated with histologically or cytologically confirmed nonmetastatic CRC previously and now relapse with metastatic disease are also eligible, irrespective of previous radiochemotherapy and/or adjuvant chemotherapy
- •Patients must have measurable disease on CT scan or MRI to be performed within 6 weeks before randomization (measurability criteria according to RECIST 1.1, non-nodal lesions ≥10 mm, lymph nodes ≥15mm) OR evaluable disease i.e. patient with nonmeasurable metastases but elevated serum tumor-marker (CEA at least >2xULN).
- •Command of written and spoken language allowing for informed consent and for filling in trial questionnaires.
- •Baseline patient-reported outcomes (PROs) have been completed.
- •WHO performance status 0-
- •Age ≥18 years
排除标准
- •Pre-existing severe medical conditions precluding participation in a physical activity program as determined by the local investigator. Such conditions include: chronic heart failure (greater than NYHA II), recent myocardial infarction (less than 3 months ago), unstable angina pectoris, clinically significant arrhythmias, uncontrolled hypertension with repeated systolic blood pressure above 160mmHg, and COPD (requiring oxygen supply or GOLD stadium greater than 2).
- •Inability to ride a cycle ergometer e.g. for musculoskeletal reasons.
- •Patients in whom all CRC metastases have been removed surgically. It is allowed to include patients for whom metastasectomy might be an option if chemotherapy induces a significant response.
- •Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes).
- •Concurrent treatment in a trial with experimental drugs or other anti-cancer therapy, which are hypothesized to alter tumor progression. Participation in an observational trial or a translational trial is allowed. Palliative radiotherapy is allowed.
- •Psychiatric disorder precluding understanding of trial information, giving informed consent, filling out PRO forms, or interfering with compliance.
- •Any psychological, familial, sociological or geographical condition potentially hampering proper compliance with the trial protocol.
结局指标
主要结局
Change in Patient-reported symptoms as measured by ESAS-r
时间窗: in at week 6, 12, 18, 24, 48
The ESAS-r is a summary score ranging from 0 to 100 with lower scores representing better quality of life of the patients.
Progression-free survival (PFS)
时间窗: every 8 or 9 weeks during one year
Change between 2 tumor assessments
次要结局
- Overall survival(after progression (expected 1 year) lifelong follow-up)
- Chemotherapy-completion-rate(week 6, 12, 18, and 24)
- Best Objective Response(at week 8 or 9 during one year)
- Selected adverse events(day 1 of each cycle (every 8 or 9 weeks))
- Initiation or increase of anti-hypertensive drugs(day 1 of each cycle (every 8 or 9 weeks) for one year)