Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Pre-treatment Loss of Independent Activities of Daily Living

Study type: Observational

Funder types: Other

Identifiers

NCT01752751

121731 (Other Identifier)

LCCC 1224

1224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

50 participants in 1 patient group

Cancer Patients Age 65 or above

Description:

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.