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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT06016868
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* FIGO 2018 stage IIB and IIIC1\[38\]
* Treatment with exclusive chemoradiation including brachytherapy
* Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer
* Has radiographically evaluable disease, measurable per RECIST 1.1
* Negative pregnancy test
* Adequate hematologic, renal, and hepatic functions, with following blood tests:
Neutrophils \> 1500/μL Platelets \> 100.000/ μL Hemoglobin \> 9 g/dL Serum creatinine \< 1.8 mg/dL Total bilirubin \< 3 mg/ dL LDH \< 3x normal value GOT \< 3x normal value GPT \< 3x normal value ALP \< 3 x normal value
Exclusion Criteria:
* Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc)
* Neo-adjuvant treatment
* Patients included in other clinical trials
* Patients refusing to sign informed consent
* Contraindications to radiotherapy
* Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT06016868
Study Brief:
Protocol Section:
NCT06016868