Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

NCT ID: NCT01752751

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-03-31

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.

Conditions

Pre-treatment Loss of Independent Activities of Daily Living

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpha Omega Alpha Honor Medical Society

UNKNOWN

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bhishamjit Chera, MD

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncology UNC Cancer Hospital

Noam VanderWalde, MD

Role: STUDY_DIRECTOR

Radiation Oncology UNC Cancer Hospital

Locations

Radiation Oncology Clinic - UNC Cancer Hospital

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28258889 (View on PubMed)

Other Identifiers

1224

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

121731

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 1224

Identifier Type: -

Identifier Source: org_study_id