MOST: Mediterranean Oncology Senior Tests

Aged 70 or Older Clinical Trial

— MOST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148731
• Other study ID #: ASRO101
• Status: Completed
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: January 2019
• Source: Association Sud pour la Recherche en Oncogériatrie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged 70 or Older
• Colon Cancer Patients Receiving Chemotherapy in the Adjuvant or Metastatic Setting
• Colonic Neoplasms

Intervention

Other:
• Frailty markers
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

Locations

Country	Name	City	State
France	Hôpital d'Aix en Provence	Aix en Provence
France	Centre Hospitalier de la Dracénie	Draguignan
France	Hôpital Européen Marseille	Marseille
France	Institut Paoli Calmette	Marseille
France	Pôle de Gérontologie, Service de Gériatrie Aigue et Thérapeutique	Nice
France	Hôpital de Pontoise Centre Hospitalier René Dubos	Pontoise, Val-d'Oise
France	Centre Hospitalier Universitaire Intercommunal des Alpes du Sud	Sisteron
France	Centre Hospitalier Intercommunal	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Association Sud pour la Recherche en Oncogériatrie

Country where clinical trial is conducted

France, 

References & Publications (2)

Retornaz F, Monette J, Batist G, Monette M, Sourial N, Small D, Caplan S, Wan-Chow-Wah D, Puts MT, Bergman H. Usefulness of frailty markers in the assessment of the health and functional status of older cancer patients referred for chemotherapy: a pilot study. J Gerontol A Biol Sci Med Sci. 2008 May;63(5):518-22. — View Citation

Retornaz F, Seux V, Sourial N, Braud AC, Monette J, Bergman H, Soubeyrand J. Comparison of the health and functional status between older inpatients with and without cancer admitted to a geriatric/internal medicine unit. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):917-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse Events	The primary endpoint analysis is defined by the relationship between the CGA (Comprehensive Geriatric Assessment) and frailty markers on the one hand and the occurrence of adverse events on the other. The effect of each tool will be evaluated using a Cox model. The results will be adjusted on the main prognostic factors (age, type and stage of cancer).	up to 18 months
Secondary	Performance of the brief screening tool	A second analysis will also evaluate the performance of the brief screening tool by determining its efficiency (specificity, sensitivity, positive and negative predictive values and accuracy) within the sample population in comparison to the CGA's and frailty markers. Estimations will be computed with a 95 % confidence interval.	3, 6, 12 and 18 months