Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Number of patients completing planned treatment without dose reductions
研究概览
简要总结
GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail, elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive geriatric assessment and intervention before and during treatment with chemotherapy.
The hypotheses are: Optimizing the health conditions and functional status of frail elderly patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will lead to a higher grade of completing the planned chemotherapy and at higher dose intensity. This will also result in a higher overall survival and improve quality of life.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frail according to the screening tool G8 ( ≤14 / 17points)
- •Performance status 0-2 and life expectancy ≥ 3 months
- •Patients who have undergone surgery for stage III / high-risk stage II colorectal cancer or patients with unresectable or metastatic disease
- •Are assessed to receive adjuvant chemotherapy or first -line chemotherapy
- •Meets the criteria to receive preventive chemotherapy with 5-FU or capecitabine +/- oxaliplatin or first -line chemotherapy with 5-FU / irinotecan and / or oxaliplatin , capecitabine +/- possibly with the addition of immunotherapy in the form of cetuximab , panitumumab or bevacizumab.
- •Informed written and oral consent
排除标准
- •Other malignancy except basal cell carcinoma and squamous cell carcinoma in situ cervicis uteri in 5 years
- •Patients in simultaneously drug trials
- •The patient must not have previously received adjuvant chemotherapy in the GERICO Protocol
研究组 & 干预措施
Control group
The control group receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change in treatment or progression. If the patient has other health problems, those issues will be assessed either by the oncologist or by the general practitioner. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
Intervention group
The intervention group also receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change of treatment or progression. They will simultaneously receive full geriatric assessement and intervention. The clinical examination includes laboratory parameters, review of medication list, psycho-cognitive assessement, screening for malnutrition and need of physiotherapy, optimizing social support. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
干预措施: Intervention group (Other)
结局指标
主要结局
Number of patients completing planned treatment without dose reductions
时间窗: 12 month after randomization
次要结局
- Occurrence of dose reductions(1 month after end of treatment)
- delay of treatment(1 month after end of treatment)
- Adverse events to treatment(1 month after end of treatment)
- Quality of Life prior(at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months.)
- time to recurrence(up to 80 months)
- Cancer specific mortality(up to 80 months)
- Survival(up to 80 months)
研究者
Cecilia Lund
MD
University of Copenhagen