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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Non-ovarian Gynecological Cancers

Study type: Observational

Funder types: Other

Identifiers

NCT02003430

LCCC1321

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

≥65 years old

Description:

20 patients greater than or equal to 65 years of age

<65 years old

Description:

20 patients less than 65 years of age