NCT02748811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

4.3 years

First QC Date

March 31, 2016

Last Update Submit

September 24, 2019

Conditions

Colorectal Neoplasms

Keywords

elderlyintervention studygeriatricschemotherapy

Outcome Measures

Primary Outcomes (1)

  • Number of patients completing planned treatment without dose reductions

    12 month after randomization

Secondary Outcomes (7)

  • 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

  • time to recurrence

    up to 80 months

  • Survival

    up to 80 months

  • +2 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

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

ACTIVE COMPARATOR

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

Interventions

Intervention groupOTHER

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.

Also known as: Comprehensive geriatric assessement and intervention
Intervention group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology. Herlev and Gentofte Hospital

Herlev, Danmark, 2730, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 33828260DERIVED

  • 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.

    PMID: 28659138DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Cecilia M Lund, MD

    Department of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 22, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)