The effect of geriatric intervention in frail elderly patients receiving chemotherapy for colorectal cancer: a randomized trial (GERICO)

C M Lund, K K Vistisen, C Dehlendorff, F Rønholt, J S Johansen, D L Nielsen, C M Lund, K K Vistisen, C Dehlendorff, F Rønholt, J S Johansen, D L Nielsen

Abstract

Background: Better surgical techniques, chemotherapy and biological therapy have improved survival in patients with colorectal cancer (CRC), most markedly in younger patients. About half of patients over 70 years receive dose reductions or early treatment discontinuation of the planned adjuvant or first-line treatment due to side effects. The Comprehensive Geriatric Assessment (CGA) is a multidisciplinary evaluation of an elderly individual's health status. This assessment in older patients with cancer can predict survival, chemotherapy toxicity and morbidity.

Methods: This randomized phase II trial (GERICO) is designed to investigate whether comprehensive geriatric assessment and intervention before and during treatment with chemotherapy in frail elderly patients with stages II-IV CRC will increase the number of patients completing chemotherapy. All patients ≥70 years in whom chemotherapy for CRC is planned to start at Herlev and Gentofte Hospital are screened for frailty using the G8 questionnaire at the first visit to the outpatient clinic. The G8 questionnaire is a multi-domain screening tool to identify frail or vulnerable patients at risk of increased toxicity and morbidity. Frail patients are offered inclusion and are then randomized to two groups (the intervention group and the control group). Patients in the intervention group receive a full geriatric assessment of comorbidity, medication, psycho-cognitive function, physical, functional and nutrition status, and interventions are undertaken on identified health issues. Simultaneously, they are treated for their cancer according to international guidelines. Patients in the control group receive the same chemotherapy regimens and standard of care. Primary outcome is number of patients completing scheduled chemotherapy at starting dose. Secondary outcomes are dose reductions, treatment delays, toxicity, time to recurrence, survival, cancer-related mortality and quality of life.

Discussion: This ongoing trial is one of the first to evaluate the effect of geriatric intervention in frail elderly patients with CRC. The trial will provide new and valuable knowledge about whether it is beneficial for the elderly patient undergoing chemotherapy to be treated simultaneously by a geriatrician.

Trial registration: ClinicalTrials.gov ID: NCT02748811 . The trial was registered retrospectively; registration date 04/28/2016.

Keywords: Chemotherapy; Colorectal cancer; Comprehensive geriatric assessment; Elderly; Frail; Intervention.

Conflict of interest statement

Authors’ information

CL and FR are geriatricians. KK, DN and JSJ are oncologists. CD is a statistician.

Ethics approval and consent to participate

The name of the study is GERICO, and the study protocol “The effect of geriatric intervention in frail elderly patients treated with chemotherapy for colorectal cancer” version 1.3 has been approved by the Regional Ethics Committee (VEK ref. H-7-2014-015). Any protocol modifications will be communicated to the Regional Ethics Committee and to all financially supportive organizations. The research team will obtain oral and written consent from all participants before inclusion. Trial results will be communicated to all participants and in publications.

Consent for publication

Not applicable.

Competing interests

None of the authors have any conflicts of interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1.
Fig. 1.
Trial status

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