Clinical trial NCT02003430: Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers
Official title: Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-ovarian Gynecological Cancers
Keywords: gynecologic malignancy
non-ovarian gynecological cancer
cervical cancer
vaginal cancer
vulvar cancer
endometrial cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 18 years of age or above with a diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment with curative intent at the Department of Radiation Oncology at UNC Chapel Hill.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-treatment I-ADL dependency
timeFrame: Pre-treatment
Secondary outcomes:
measure: Poor adherence to treatment
timeFrame: During or 4-8 weeks post-treatment
Other outcomes:
measure: Patient-reported acute grade 3-5 radiation related toxicities
timeFrame: During treatment and 4-8 weeks post-treatment
measure: Provider-reported grade 3-5 acute radiation related toxicities
timeFrame: During treatment and 4-8 weeks post-treatment
Locations:
city: Chapel Hill
country: United States
facility: UNC Department of Radiation Oncology Clinic
state: North Carolina
Study officials:
affiliation: Department of Radiation Oncology, University of North Carolina Chapel Hill
name: Mahesh Varia, MD, ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Unverisity of North Carolina Chapel Hill
name: Noam VanderWalde, MD
role: STUDY_DIRECTOR
References: