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

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Other: Intervention group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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. | |
| Active Comparator: Intervention group<br>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<br>* 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.<br>* Other names: Comprehensive geriatric assessement and intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients completing planned treatment without dose reductions |  | 12 month after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of dose reductions | Data will be collected by reviewing patients medical charts | 1 month after end of treatment | 
| delay of treatment | Data will be collected by reviewing patients medical charts | 1 month after end of treatment | 
| 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. | 1 month after end of treatment | 
| time to recurrence | Data will be collected by reviewing patients medical charts | up to 80 months | 
| Survival | Data will be collected by reviewing patients medical charts | up to 80 months | 
| Cancer specific mortality | Data will be collected by reviewing patients medical charts | up to 80 months | 
| Quality of Life prior | Quality of life questionnaires will be filled out by the participants | at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, intervention study, geriatrics, chemotherapy