Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

Study Overview
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Brief Summary
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A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments. The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.

Detailed Description
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A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance. The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1). Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire. The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.

Official Title
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Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment

Conditions
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Pre-treatment Loss of Independent Activities of Daily Living

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥Age 65 years (no upper age limit) Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment. Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill Able to read English (required for CGA) Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208) Exclusion Criteria: ≥Age 65 years (no upper age limit) Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment. Consented for receipt of EBRT at UNC Chapel Hill Able to read English (required for CGA) Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Patients Age 65 or above<br>Cancer patients age 65 years or above with a diagnosis of head and neck cancer or lung cancer with radiotherapy or chemoradiotherapy planned as part of curative standard treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy | To assess the association between pre-treatment loss of at least one independent activity of daily living (I-ADL) on the CGA and poor tolerance to radiation therapy | 4-8 weeks post-radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and the occurrence of any patient-reported toxicity from radiation therapy | To assess the association between pre-treatment loss of at least one I-ADL on the CGA and the occurrence of any patient-reported acute grade 3-5 toxicity from radiation therapy | 4-8 weeks post-radiation therapy | 
| Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures | To assess the association between pre-treatment loss of at least one I-ADL on the CGA and changes in QoL measures, as evaluated by the EORTC-QLQ-C30 throughout radiation therapy | 4-8 weeks post radiation therapy | 
| Comparison of physician and patient-reported acute grade 3-5 toxicities | To compare physician-reported acute grade 3-5 toxicities to patient-reported grade 3-5 acute toxicities in this older adult population. | 4-8 weeks post-radiation therapy | 
| Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy | To assess the association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to and/or patient reported and physician reported acute grade 3-5 toxicity from radiation therapy | 4-8 weeks post-radiation therapy | 
| Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment | To explore the association between baseline components of the CGA (other than I-ADL) and poor tolerance to or occurrence of any patient-reported acute grade 3-5 toxicity from radiation treatment. | 4-8 weeks post-radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head cancer, Lung cancer, Neck cancer