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


N/A
65 Years
N/A
Open (Enrolling by invite only)
Both
Pre-treatment Loss of Independent Activities of Daily Living

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Trial Information

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


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

4-8 weeks post-radiation therapy

Safety Issue:

No

Principal Investigator

Bhishamjit Chera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Oncology UNC Cancer Hospital

Authority:

United States: Institutional Review Board

Study ID:

121731

NCT ID:

NCT01752751

Start Date:

November 2012

Completion Date:

December 2014

Related Keywords:

  • Pre-treatment Loss of Independent Activities of Daily Living
  • Neck cancer
  • Head cancer
  • Lung cancer

Name

Location

Radiation Oncology Clinic - UNC Cancer HospitalChapel Hill, North Carolina  27599