Overview

This trial is active, not recruiting.

Conditions colon cancer patients receiving chemotherapy in the adjuvant or metastatic setting, aged 70 or older
Treatment frailty markers
Sponsor Association Sud pour la Recherche en Oncogériatrie
Start date January 2010
End date December 2014
Trial size 180 participants
Trial identifier NCT02148731, ASRO101

Summary

MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are better at detecting vulnerable patients and that they are a better "Adverse Events" predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients referred for chemotherapy. The second hypothesis is that a brief screening tool based on a combination of some frailty markers and some used in the CGA would help the oncologist detect patients requiring a more complete geriatric assessment

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Functional status, Comorbidities, Objective physical performance, Nutrition, Cognition, Depression, Social support
frailty markers Mobility
Brief screening assessment, CGA and frailty markers will be evaluate at inclusion. CGA and frailty markers will be evaluated at 3, 6, 12 and 18 months after the beginning of chemotherapy. Criteria for toxicity and adverse outcomes will be recorded at each cycle or visits

Primary Outcomes

Measure
Occurrence of Adverse Events
time frame: up to 18 months

Secondary Outcomes

Measure
Performance of the brief screening tool
time frame: 3, 6, 12 and 18 months

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - Patients with colon cancer with or without metastases - Age ≥ 70 years - Patients did not start chemotherapy yet Exclusion Criteria: - Patients terminally ill with a life expectancy <3 months - Patients who have started chemotherapy or hormonal therapy

Additional Information

Official title Longitudinal Study Comparing Markers of Frailty in Geriatric Assessment to Detect Vulnerability to Chemotherapy in Patients Aged 70 Years or Older With Colon Cancer
Principal investigator Frédérique RETORNAZ, MD
Description For older cancer patients, Comprehensive Geriatric Assessment (CGA) is recommended in order to help the oncologist in his decision making. However, the implementation of the CGA in oncologic setting presents major limitations; The CGA is time consuming, costly in terms of resources and is not standardized. Moreover, recent studies show that the CGA, used as the gold standard, may have a ceiling effect in detecting vulnerability in older cancer patients. Several authors suggest that a more sensitive approach, using frailty markers may be a better way to detect potential vulnerability in older cancer patients. In this study, for each patient, a brief screening assessment, a full CGA and the assessment of frailty markers will be completed at inclusion. The brief screening assessment will be based on self report questionnaire (4 items of instrumental Activities of Daily Living + 2 items of nutritional assessment) and one physical measure (one-leg standing balance test). The CGA will be based on seven domains (and their assessment tools): functional status, comorbidities, objective physical performance, nutrition, cognition, depression, and social support. Five frailty markers (as described by Fried and al) will be evaluated: nutrition, mobility, energy, physical activity and grip strength. CGA and frailty markers will be completed at 3, 6, 12 and 18 months after the beginning of chemotherapy as well as oncologic criteria (treatment toxicities, treatment modification such as decrease or change or end of chemotherapy, percentage of chemotherapy dose received, cancer related death) and geriatric criteria for adverse outcomes (functional, nutritional or cognition decline, hospitalization or consultation with their general practitioner, death for other causes).
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Association Sud pour la Recherche en Oncogériatrie.