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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02003430
First received: November 18, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition
Non-ovarian Gynecological Cancers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Pre-treatment I-ADL dependency [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]
    Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.


Secondary Outcome Measures:
  • Poor adherence to treatment [ Time Frame: During or 4-8 weeks post-treatment ] [ Designated as safety issue: No ]

    Poor adherence to treatment is defined by at least one of the following:

    1. > 3 day treatment delay secondary to treatment related toxicity during radiation therapy.
    2. Hospitalization secondary to treatment related toxicity during or up to 4-8 weeks post radiation therapy.
    3. Unplanned dose reductions in either radiation or concurrent chemotherapy secondary to treatment related toxicity during radiation therapy
    4. Unplanned change in concurrent chemotherapy regimen secondary to treatment related toxicity during radiation therapy.


Other Outcome Measures:
  • Patient-reported acute grade 3-5 radiation related toxicities [ Time Frame: During treatment and 4-8 weeks post-treatment ] [ Designated as safety issue: No ]
    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.

  • Provider-reported grade 3-5 acute radiation related toxicities [ Time Frame: During treatment and 4-8 weeks post-treatment ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
≥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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003430

Locations
United States, North Carolina
UNC Department of Radiation Oncology Clinic
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02003430     History of Changes
Other Study ID Numbers: 132824, LCCC 1321
Study First Received: November 18, 2013
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
gynecologic malignancy
non-ovarian gynecological cancer
cervical cancer
vaginal cancer
vulvar cancer
endometrial cancer

ClinicalTrials.gov processed this record on November 25, 2014