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

Functional Assessment and Radiation Adherence/Toxicity in Older and Younger 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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Department of Radiation Oncology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
≥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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported acute grade 3-5 radiation related toxicities	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.	During treatment and 4-8 weeks post-treatment
Provider-reported grade 3-5 acute radiation related toxicities	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	During treatment and 4-8 weeks post-treatment

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: endometrial cancer; cervical cancer; vaginal cancer; vulvar cancer; gynecologic malignancy; non-ovarian gynecological cancer
• Other Study ID Numbers: LCCC1321