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Completed

NCT Number: NCT02003430

Radiation Adherence/Toxicity in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pre-treatment I-ADL dependency

    Time frame: Pre-treatment

    Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.

Secondary outcomes

  1. Poor adherence to treatment

    Time frame: During or 4-8 weeks post-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.

Other outcomes

  1. Patient-reported acute grade 3-5 radiation related toxicities

    Time frame: During treatment and 4-8 weeks post-treatment

    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.

  2. Provider-reported grade 3-5 acute radiation related toxicities

    Time frame: During treatment and 4-8 weeks post-treatment

    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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2013
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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