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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT07164534
Eligibility Criteria:
Inclusion Criteria:
* Female subjects aged 18 years or above with histologically proven locally advanced squamous cell or adenocarcinoma of the cervix
* Subjects eligible for RT and planned for definitive RT +/- chemotherapy with brachytherapy.
* Subjects who exceed the dose constraints of:
* Rectum/sigmoid D 2cm³ EQD2 ³ by more than 70 Gy, or
* Bladder D 2cm³ EQD2 ³ more than 80 Gy
* Subjects with adequate haematological, renal, hepatic and coagulation profiles and laboratory parameters within the following ranges:
* Haemoglobin: ≥ 8 g/dl
* ANC ≥ 1,500/mm\^3
* Platelet count 100,000/mm\^3
* Creatinine Clearance: ≥ 50 ml/min (as per Cockcroft-Gault formula)
* Bilirubin: ≤ 2 x Upper limit of normal (ULN)
* AST and ALT: ≤ 1.5 x ULN
* Subjects willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
* Ability to understand and willingness to sign an informed consent document
Exclusion Criteria:
* Subjects with known hypersensitivity or contraindication to the study drug or to any known component of the study drug formulation
* Subjects with clinically significant decreased hematologic reserves, with major organ failure, severe electrolyte or metabolic abnormalities, any active infection or any other medical condition that may interfere with the ability to receive study treatment
* HIV positive patients
* Subjects with a history of blood dyscrasias
* Subjects consuming any other concurrent investigational agents
* Subjects with any other previous or current malignancy or RT that is likely to interfere with the protocol treatment, or any other condition which, according to the principal investigator, might make an individual unsuitable for this study
* Subjects participating in any other clinical study within 90 days before enrolment in the study
* Subjects on active anti-coagulant treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07164534
Study Brief:
Protocol Section:
NCT07164534