Non-ovarian Gynecological Cancers
Conditions
Keywords
gynecologic malignancy, non-ovarian gynecological cancer, cervical cancer, vaginal cancer, vulvar cancer, endometrial cancer
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.
Interventions
None listed
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-treatment I-ADL dependency | Pre-treatment | Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Poor adherence to treatment | During or 4-8 weeks post-treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported acute grade 3-5 radiation related toxicities | 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 | 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 |
Countries
United States
Outcome results
None listed