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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT04516135
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically documented gynecologic cancer with prior or current evidence of metastatic disease
* Measurable pelvic disease with any pain and/or bleeding
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 3
* Estimated life expectancy \> 3 months at discretion of treating physician
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
* Patient able to provide properly obtained written informed consent
* Gynecologic Section Radiation Oncology Quality Assurance (QA) for eligibility for single fraction radiation treatment
Exclusion Criteria:
* Prior pelvic radiation therapy that would make treatment unsafe at the discretion of the treating physician
* Systemic therapy concurrently or within 21 days of first dose of radiation
* Concurrent participation in another interventional radiation therapy trial concurrently or within 30 days of study consent. Note: Patients who are participating in systemic clinical trials and non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation
* Known second malignancy that requires active treatment (at the discretion of the primary investigator)
* Documented psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Pregnant or breastfeeding at any point starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04516135
Study Brief:
Protocol Section:
NCT04516135