Clinical trial NCT02748811: Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
Official title: Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: elderly
intervention study
geriatrics
chemotherapy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2016-04-22
Enrollment: 140
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Number of patients completing planned treatment without dose reductions
timeFrame: 12 month after randomization
Secondary outcomes:
measure: Occurrence of dose reductions
timeFrame: 1 month after end of treatment
measure: delay of treatment
timeFrame: 1 month after end of treatment
measure: Adverse events to treatment
timeFrame: 1 month after end of treatment
measure: time to recurrence
timeFrame: up to 80 months
measure: Survival
timeFrame: up to 80 months
measure: Cancer specific mortality
timeFrame: up to 80 months
measure: Quality of Life prior
timeFrame: at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology. Herlev and Gentofte Hospital
state: Danmark
Study officials:
affiliation: Department of Oncology
name: Cecilia M Lund, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.