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Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer (GERICO)

2019年9月24日 更新者：Cecilia Lund、University of Copenhagen

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
    • Danmark
      • Herlev、Danmark、丹麦、2730
        • Department of Oncology. Herlev and Gentofte Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

70年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：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.
有源比较器：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.
其他：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. The participants 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.
其他名称：
  • Comprehensive geriatric assessement and intervention

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of patients completing planned treatment without dose reductions
大体时间：12 month after randomization
12 month after randomization

次要结果测量

结果测量
措施说明
大体时间
Occurrence of dose reductions
大体时间：1 month after end of treatment
Data will be collected by reviewing patients medical charts
1 month after end of treatment
delay of treatment
大体时间：1 month after end of treatment
Data will be collected by reviewing patients medical charts
1 month after end of treatment
Adverse events to treatment
大体时间：1 month after end of treatment
Adverse events will be registered for every cycle of treatment and assessed by an oncologist according to CTC- criteria version 4.0.
1 month after end of treatment
time to recurrence
大体时间：up to 80 months
Data will be collected by reviewing patients medical charts
up to 80 months
Survival
大体时间：up to 80 months
Data will be collected by reviewing patients medical charts
up to 80 months
Cancer specific mortality
大体时间：up to 80 months
Data will be collected by reviewing patients medical charts
up to 80 months
Quality of Life prior
大体时间：at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months.
Quality of life questionnaires will be filled out by the participants
at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Copenhagen

合作者

Danish Cancer Society

调查人员

  • 首席研究员：Cecilia M Lund, MD、Department of Oncology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年5月1日

初级完成 (实际的)

2019年9月1日

研究完成 (实际的)

2019年9月1日

研究注册日期

首次提交

2016年3月31日

首先提交符合 QC 标准的

2016年4月21日

首次发布 (估计)

2016年4月22日

研究记录更新

最后更新发布 (实际的)

2019年9月26日

上次提交的符合 QC 标准的更新

2019年9月24日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GERICO

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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