Clinical trial NCT01752751: Predicting Tolerance to Radiation Therapy in Older Adults With Cancer
Official title: Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-treatment Loss of Independent Activities of Daily Living
Keywords: Neck cancer
Head cancer
Lung cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Alpha Omega Alpha Honor Medical Society
First posted: 2012-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age ≥ 65 years of age, with one of the inclusion diagnoses, and an appointment for CT simulation for planning of radiation therapy at UNCH department of radiation oncology will be assessed for inclusion for this study.

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy
timeFrame: 4-8 weeks post-radiation therapy
Secondary outcomes:
measure: 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
timeFrame: 4-8 weeks post-radiation therapy
measure: Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures
timeFrame: 4-8 weeks post radiation therapy
measure: Comparison of physician and patient-reported acute grade 3-5 toxicities
timeFrame: 4-8 weeks post-radiation therapy
measure: Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy
timeFrame: 4-8 weeks post-radiation therapy
measure: Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment
timeFrame: 4-8 weeks post-radiation therapy
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Radiation Oncology Clinic - UNC Cancer Hospital
state: North Carolina
Study officials:
affiliation: Radiation Oncology UNC Cancer Hospital
name: Bhishamjit Chera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiation Oncology UNC Cancer Hospital
name: Noam VanderWalde, MD
role: STUDY_DIRECTOR
References:
citation: VanderWalde NA, Deal AM, Comitz E, Stravers L, Muss H, Reeve BB, Basch E, Tepper J, Chera B. Geriatric Assessment as a Predictor of Tolerance, Quality of Life, and Outcomes in Older Patients With Head and Neck Cancers and Lung Cancers Receiving Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):850-857. doi: 10.1016/j.ijrobp.2016.11.048. Epub 2016 Dec 2.