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:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT07276360
Eligibility Criteria:
Inclusion Criteria:
* Females aged 18 years or older
* Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment
* Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3, IIA, IIB, IIIA, IIIB, or IIIC
* Able to provide written informed consent in English, Luganda, Runyankole, or Lango
* Willing to attend post-treatment follow-up for up to 12 months
* Fit for concurrent chemotherapy with cisplatin
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2
* Absolute neutrophil count ≥ 1,500 cells/mm\^3 (1.5 x 10\^9/L)
* Platelets ≥ 100,000 cells/mm\^3 (100 x 10\^9/L)
* Hemoglobin ≥ 9.0 g/dL
* Leukocyte count ≥ 4,000 cells/mm\^3 (4.0 x 10\^9/L)
* Creatinine clearance \> 60 mL/mins, calculated using the Cockcroft-gault equation for women
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times the upper limit of normal (ULN)
* Total bilirubin \< 2 x ULN unless attributed to the use of antiretroviral therapy (ART)
* HIV-positive participants must be on a stable ART regimen for at least 6 weeks prior to enrollment
Exclusion Criteria:
* Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention
* Clinical and/or radiological evidence of distant metastases
* Prior pelvic or abdominal radiotherapy
* Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment
* History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment
* Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated
* Concurrent untreated invasive malignancy
* Uncontrolled concurrent medical/psychiatric diagnosis that would limit compliance with study requirements
* Uncontrolled HIV infection, especially HIV viral load \> 2,000 copies/mL
* Participants with CD4 counts \< 200 cells/mm\^3
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07276360
Study Brief:
Protocol Section:
NCT07276360