Clinical trial · Observational
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
NCT02003430CI-TRIAL-00031352completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-ovarian Gynecological Cancers | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- ≥65 years old
- description
- 20 patients greater than or equal to 65 years of age
- label
- <65 years old
- description
- 20 patients less than 65 years of age
Primary outcomes (1)
- measure
- Pre-treatment I-ADL dependency
- timeFrame
- Pre-treatment
- description
- Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.
Secondary outcomes (1)
- measure
- Poor adherence to treatment
- timeFrame
- During or 4-8 weeks post-treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.