This trial is active, not recruiting.

Condition non-ovarian gynecological cancers
Sponsor UNC Lineberger Comprehensive Cancer Center
Start date September 2013
End date December 2016
Trial size 15 participants
Trial identifier NCT02003430, 132824, LCCC 1321


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
20 patients greater than or equal to 65 years of age
20 patients less than 65 years of age

Primary Outcomes

Pre-treatment I-ADL dependency
time frame: Pre-treatment

Secondary Outcomes

Poor adherence to treatment
time frame: During or 4-8 weeks post-treatment

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers
Principal investigator Mahesh Varia, MD, ChB
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.