Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
- Conditions
- Colorectal Neoplasms
- Interventions
- Other: Intervention group
- Registration Number
- NCT02748811
- Lead Sponsor
- University of Copenhagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group 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.
- Primary Outcome Measures
Name Time Method Number of patients completing planned treatment without dose reductions 12 month after randomization
- Secondary Outcome Measures
Name Time Method Occurrence of dose reductions 1 month after end of treatment Data will be collected by reviewing patients medical charts
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.
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
time to recurrence up to 80 months 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
Survival up to 80 months Data will be collected by reviewing patients medical charts
Trial Locations
- Locations (1)
Department of Oncology. Herlev and Gentofte Hospital
🇩🇰Herlev, Danmark, Denmark