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

September 24, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Herlev, Danmark, Denmark, 2730
        • Department of Oncology. Herlev and Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.
Other: 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.
Other Names:
  • Comprehensive geriatric assessement and intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients completing planned treatment without dose reductions
Time Frame: 12 month after randomization
12 month after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of dose reductions
Time Frame: 1 month after end of treatment
Data will be collected by reviewing patients medical charts
1 month after end of treatment
delay of treatment
Time Frame: 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
Time Frame: 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
Time Frame: up to 80 months
Data will be collected by reviewing patients medical charts
up to 80 months
Survival
Time Frame: up to 80 months
Data will be collected by reviewing patients medical charts
up to 80 months
Cancer specific mortality
Time Frame: up to 80 months
Data will be collected by reviewing patients medical charts
up to 80 months
Quality of Life prior
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Danish Cancer Society

Investigators

  • Principal Investigator: Cecilia M Lund, MD, Department of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERICO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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