Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers
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|ClinicalTrials.gov Identifier: NCT02003430|
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : January 24, 2018
|Condition or disease|
|Non-ovarian Gynecological Cancers|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
≥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
- 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.
- 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.
- 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.
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003430
|United States, North Carolina|
|UNC Department of Radiation Oncology Clinic|
|Chapel Hill, North Carolina, United States, 27599|
|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|