Page 11 - Delaware Medical Journal - January 2018
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CANCER CLINICAL TRIAL
CASE REPORT
URCC 13059:
PROTOCOL OF THE MONTH
(GAP) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer: Reducing Chemotherapy Toxicity in Older Adults
Primary Objective:
Our primary aim is to determine if providing information regarding GA plus GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in participants aged 70 and over with advanced cancer starting a new treatment regimen. The regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity. months of starting a new treatment regimen.
Secondary Objectives:
The principal secondary endpoint for this study is the proportion of participants that are alive at 6 months after study entry.
advanced cancer.
We will compare treatment decisions (as measured by relative dose intensity of the agents administered in the GA-driven recommendations implemented for older participants starting a new treatment regimen for advanced cancer.
Exploratory Aim:
An exploratory aim is to determine whether providing the oncology team with GA information and GA-driven recommendations can slow functional and physical decline in older patients with advanced cancer. Functional status will be measured with self-reported Instrumental Activities of Daily Living score. Physical performance will be measured with the OARS Physical Health Subscale, and the Short Physical Performance Battery.
Eligibility Criteria:
Male or female 70 years of age or older.
Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration. The treatment
regimen is up to the discretion of the treating oncology physician. The regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity.Patients who will receive monoclonal antibody therapy toxicity similar to chemotherapy. These therapies can be used in combination with chemotherapy, as a single agent, or in combination with each other.
come in for study visits.
Treatment:
ARM1: NCORPpracticesiteswithIRBapprovaloftheprotocolwillberandomizedtoreceiptofGAplusGAdriven
ARM 2: Usual Care
The Delaware Cancer Treatment Program (DCTP)
provides medical insurance coverage to uninsured Delawareans for the treatment of cancer.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
Del Med J | January 2018 | Vol. 90 | No. 1
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