Colorectal Neoplasms
Conditions
Keywords
elderly, intervention study, geriatrics, chemotherapy
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.
Interventions
OTHERIntervention 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.
Sponsors
Danish Cancer Society
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients completing planned treatment without dose reductions | 12 month after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| delay of treatment | 1 month after end of treatment | Data will be collected by reviewing patients medical charts |
| Adverse events to treatment | 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. |
| time to recurrence | up to 80 months | Data will be collected by reviewing patients medical charts |
| Occurrence of dose reductions | 1 month after end of treatment | Data will be collected by reviewing patients medical charts |
| Cancer specific mortality | up to 80 months | Data will be collected by reviewing patients medical charts |
| Quality of Life prior | 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 |
| Survival | up to 80 months | Data will be collected by reviewing patients medical charts |
Countries
Denmark
Outcome results
None listed