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

Colorectal Neoplasms Clinical Trial

— GERICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748811
• Other study ID #: GERICO
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Other:
• 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. 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.

Locations

Country	Name	City	State
Denmark	Department of Oncology. Herlev and Gentofte Hospital	Herlev	Danmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients completing planned treatment without dose reductions		12 month after randomization
Secondary	Occurrence of dose reductions	Data will be collected by reviewing patients medical charts	1 month after end of treatment
Secondary	delay of treatment	Data will be collected by reviewing patients medical charts	1 month after end of treatment
Secondary	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
Secondary	time to recurrence	Data will be collected by reviewing patients medical charts	up to 80 months
Secondary	Survival	Data will be collected by reviewing patients medical charts	up to 80 months
Secondary	Cancer specific mortality	Data will be collected by reviewing patients medical charts	up to 80 months
Secondary	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.