Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT02058550
Eligibility Criteria:
Inclusion Criteria:
* Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment
* Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment.
* Patients should have a life expectancy of at least 1 year
* No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements
* No organ and marrow function requirements
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded
* No restrictions regarding use of other investigational agents
* No exclusion requirements due to co-morbid disease or intercurrent illness
* No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device
* No exclusion criteria relating to concomitant medications
* No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02058550
Study Brief:
Protocol Section:
NCT02058550