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NCT Number: NCT01752751

Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiation Oncology Clinic - UNC Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy

    Time frame: 4-8 weeks post-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

Secondary outcomes

  1. 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

    Time frame: 4-8 weeks post-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

  2. Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures

    Time frame: 4-8 weeks post radiation therapy

    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

  3. Comparison of physician and patient-reported acute grade 3-5 toxicities

    Time frame: 4-8 weeks post-radiation therapy

    To compare physician-reported acute grade 3-5 toxicities to patient-reported grade 3-5 acute toxicities in this older adult population.

  4. Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy

    Time frame: 4-8 weeks post-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

  5. Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment

    Time frame: 4-8 weeks post-radiation therapy

    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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Alpha Omega Alpha Honor Medical Society

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2012
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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