Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers
The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.
Non-ovarian Gynecological Cancers
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers|
- Pre-treatment I-ADL dependency [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.
- Poor adherence to treatment [ Time Frame: During or 4-8 weeks post-treatment ] [ Designated as safety issue: No ]
Poor adherence to treatment is defined by at least one of the following:
- > 3 day treatment delay secondary to treatment related toxicity during radiation therapy.
- Hospitalization secondary to treatment related toxicity during or up to 4-8 weeks post radiation therapy.
- Unplanned dose reductions in either radiation or concurrent chemotherapy secondary to treatment related toxicity during radiation therapy
- Unplanned change in concurrent chemotherapy regimen secondary to treatment related toxicity during radiation therapy.
- Patient-reported acute grade 3-5 radiation related toxicities [ Time Frame: During treatment and 4-8 weeks post-treatment ] [ Designated as safety issue: No ]Patient-reported acute grade 3-5 radiation related toxicities will be based on the PRO-CTCAE questionnaire during and 4-8 weeks post radiation therapy and at 6 months.
- Provider-reported grade 3-5 acute radiation related toxicities [ Time Frame: During treatment and 4-8 weeks post-treatment ] [ Designated as safety issue: No ]Provider-reported grade 3-5 acute radiation related toxicities will be based on the CTCAE (Common Toxicity Criteria for Adverse Effects) v4.03 during and 4-8 weeks post radiation therapy
Biospecimen Retention: Samples With DNA
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
≥65 years old
20 patients greater than or equal to 65 years of age
<65 years old
20 patients less than 65 years of age
There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues. Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003430
|United States, North Carolina|
|UNC Department of Radiation Oncology Clinic|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Mahesh Varia, MD, ChB||Department of Radiation Oncology, University of North Carolina Chapel Hill|
|Study Director:||Noam VanderWalde, MD||Department of Radiation Oncology, Unverisity of North Carolina Chapel Hill|