Elderly CAncer Patient

Recruiting

• Conditions: Hematologic Malignancies; Solid Cancer
• Interventions: Other: Extensive GA

• Registration Number: NCT02884375
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations.

Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment.

The objectives are:

* To assess the role of GA for decision making process for older patients with cancer

* To identify geriatric and oncologic factors associated with overall survival, treatment feasibility, toxicities, morbidities

* To develop and/or validate screening tests for frailty in geriatric oncology

* To develop and validate frailty classifications

Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study that includes all patients age 70 years or older who has a diagnosis of solid cancer or hematologic malignancies in French hospitals

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2016-08
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-25
• Last Update Submitted: 2016-08-25
• Study First Posted: 2016-08-31
• Last Update Posted: 2016-08-31
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patient aged 70 years or older
• Diagnosed cancer at all stage
• Referred to a geriatrician for GA
• Given oral non-opposition from patient or a legally mandated person

Exclusion Criteria

• Oral opposition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly cancer patient cohort	Extensive GA	Patients aged 70 years or older, who had diagnosis of cancer in participating sites (including hematologic malignancies), and referred to a geriatrician for geriatric assessment (GA)

Primary Outcome Measures

Name	Time	Method
Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment	through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).

Secondary Outcome Measures

Name	Time	Method
Overall mortality	Year 1 and 5 years follow-up
Chemotherapy toxicities using Common Terminology Criteria for Adverse Events	through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).
Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status)	through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France