Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers

Conditions
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Non-ovarian Gynecological Cancers

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥Age 18 years (no upper age limit) Diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment. Consented for receipt of External Beam Radiation Therapy (EBRT) at the University of North Carolina Chapel Hill Ability to read English (required for CGA) Curative treatment intent as defined by their radiation oncologist Negative serum pregnancy test in women of childbearing potential Exclusion Criteria: < Age 18 years Incurable cancer as defined by their radiation oncologist Planned radiation for palliative intent only Inability to complete the I-ADL section of the CGA Prior radiation to areas targeted by radiotherapy within this study Other active, invasive malignancy requiring active ongoing therapy during their radiotherapy with the exception of: Localized squamous cell carcinoma of the skin Basal-cell carcinoma of the skin Other malignancies requiring locally ablative therapy only

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ≥65 years old<br>20 patients greater than or equal to 65 years of age | |
| <65 years old<br>20 patients less than 65 years of age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-treatment I-ADL dependency | Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA. | Pre-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor adherence to treatment | 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. | During or 4-8 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gynecologic malignancy, non-ovarian gynecological cancer, cervical cancer, vaginal cancer, vulvar cancer, endometrial cancer