Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Alpha Omega Alpha Honor Medical Society
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01752751
First received: December 14, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition
Pre-treatment Loss of Independent Activities of Daily Living

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Comparison of physician and patient-reported acute grade 3-5 toxicities [ Time Frame: 4-8 weeks post-radiation therapy ] [ Designated as safety issue: No ]
    To compare physician-reported acute grade 3-5 toxicities to patient-reported grade 3-5 acute toxicities in this older adult population.

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cancer Patients Age 65 or above
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.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752751

Locations
United States, North Carolina
Radiation Oncology Clinic - UNC Cancer Hospital
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Alpha Omega Alpha Honor Medical Society
Investigators
Principal Investigator: Bhishamjit Chera, MD Radiation Oncology UNC Cancer Hospital
Study Director: Noam VanderWalde, MD Radiation Oncology UNC Cancer Hospital
  More Information

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01752751     History of Changes
Other Study ID Numbers: 121731, 1224
Study First Received: December 14, 2012
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Neck cancer
Head cancer
Lung cancer

ClinicalTrials.gov processed this record on August 21, 2014