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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT05406856
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, HPV positive or negative) with an indication for curative treatment with primary chemoradiation with concurrent cisplatin followed by 3D image-guided adaptive brachytherapy.
* Indication to include the common iliac region (minimum 5, maximum 8) or the common iliac and para-aortic regions (minimum 7, maximum 10) into the elective clinical target volume of the external beam radiotherapy.
* No distant metastasis beyond the para-aortic lymph node chain as determined by diagnostic imaging (CT or PET-CT scan)
* Age ≥ 18 years
* WHO 0-1
* Adequate systemic organ function:
* Creatinine clearance (\> 50 cc/min)
* Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements
Exclusion Criteria:
* Small cell cancer, melanoma and other rare histological types of the cervix.
* History of another primary malignancy that could conceivably be active evaluated by the study physician. Examples of exception include, but are not limited to:
* Malignancy treated with curative intent and with no known active disease ≥5 years.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Other severe diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Previous pelvic or abdominal radiotherapy
* History of active primary immunodeficiency
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g. colitis or Crohn's disease\])
* The use of immunosuppressive drugs at baseline
* Contraindications for weekly Cisplatin (or Carboplatin)
* Contraindications for the use of MRI
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05406856
Study Brief:
Protocol Section:
NCT05406856