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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intervention group
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasms focused on measuring elderly, intervention study, geriatrics, chemotherapy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology. Herlev and Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of patients completing planned treatment without dose reductions

Secondary Outcome Measures

Occurrence of dose reductions
Data will be collected by reviewing patients medical charts
delay of treatment
Data will be collected by reviewing patients medical charts
Adverse events to treatment
Adverse events will be registered for every cycle of treatment and assessed by an oncologist according to CTC- criteria version 4.0.
time to recurrence
Data will be collected by reviewing patients medical charts
Survival
Data will be collected by reviewing patients medical charts
Cancer specific mortality
Data will be collected by reviewing patients medical charts
Quality of Life prior
Quality of life questionnaires will be filled out by the participants

Full Information

First Posted
March 31, 2016
Last Updated
September 24, 2019
Sponsor
University of Copenhagen
Collaborators
Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT02748811
Brief Title
Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
Acronym
GERICO
Official Title
Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Danish Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
elderly, intervention study, geriatrics, chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention group
Other Intervention Name(s)
Comprehensive geriatric assessement and intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients completing planned treatment without dose reductions
Time Frame
12 month after randomization
Secondary Outcome Measure Information:
Title
Occurrence of dose reductions
Description
Data will be collected by reviewing patients medical charts
Time Frame
1 month after end of treatment
Title
delay of treatment
Description
Data will be collected by reviewing patients medical charts
Time Frame
1 month after end of treatment
Title
Adverse events to treatment
Description
Adverse events will be registered for every cycle of treatment and assessed by an oncologist according to CTC- criteria version 4.0.
Time Frame
1 month after end of treatment
Title
time to recurrence
Description
Data will be collected by reviewing patients medical charts
Time Frame
up to 80 months
Title
Survival
Description
Data will be collected by reviewing patients medical charts
Time Frame
up to 80 months
Title
Cancer specific mortality
Description
Data will be collected by reviewing patients medical charts
Time Frame
up to 80 months
Title
Quality of Life prior
Description
Quality of life questionnaires will be filled out by the participants
Time Frame
at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia M Lund, MD
Organizational Affiliation
Department of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology. Herlev and Gentofte Hospital
City
Herlev
State/Province
Danmark
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33828260
Citation
Lund CM, Vistisen KK, Olsen AP, Bardal P, Schultz M, Dolin TG, Ronholt F, Johansen JS, Nielsen DL. The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO). Br J Cancer. 2021 Jun;124(12):1949-1958. doi: 10.1038/s41416-021-01367-0. Epub 2021 Apr 7.
Results Reference
derived
PubMed Identifier
28659138
Citation
Lund CM, Vistisen KK, Dehlendorff C, Ronholt F, Johansen JS, Nielsen DL. The effect of geriatric intervention in frail elderly patients receiving chemotherapy for colorectal cancer: a randomized trial (GERICO). BMC Cancer. 2017 Jun 28;17(1):448. doi: 10.1186/s12885-017-3445-8.
Results Reference
derived

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

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