NCT01752751

Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pre-treatment Loss of Independent Activities of Daily Living

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-12-19
• Last updated: 2018-06-04

Locations

1 site across 1 country: United States