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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT05139368
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged \>= 18 years
* Pathologically confirmed malignancy of the cervix or endometrium. Non-epithelial histologies are permitted. Adenocarcinoma in situ is also permitted
* Patients must be status post hysterectomy for initial management of cervix or endometrial cancer
* Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Recovery to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
* Life expectancy of \> 2 years
* Chemotherapy can be administered at discretion of the treating radiation, medical, or gynecologic oncologist. Sequential therapy (radiation followed by chemotherapy) is preferred but not required
Exclusion Criteria:
* Prior abdominal or pelvic irradiation
* Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks, unless chemotherapy is administered prior to RT. If chemotherapy is administered prior to RT, consult with PI regarding acceptable time frame.
* Prior history of inflammatory bowel disease
* The diagnosis of another malignancy within =\< 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, or bladder or of the cervix)
* Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05139368
Study Brief:
Protocol Section:
NCT05139368