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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT01941966
Eligibility Criteria:
Inclusion Criteria:
* Invasive anal canal SCC histologically confirmed, T2-4 N0 M0, T (anyone) N1-3 M0 - according to TNM staging system.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
* Adequate medullar function, defined as: Absolute neutrophil count ≥ 1,5×109/L; platelets ≥100×109/L; hemoglobin ≥10g/dl.
* Serum AST (aspartato aminotransferase) and ALT (alanine aminotransferase) \< 3 × ULN (upper limit of normal).
* Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min.
* Signed written informed consent.
Exclusion Criteria:
* Major surgical procedure within 4 weeks of the beginning of the treatment.
* History of severe systemic or psychiatric disease.
* Previous treatment for anal canal carcinoma or other cancer.
* For female patients, current pregnancy and/or lactation
* Unstable angina or acute myocardial infarction within 6 months.
* Concomitant use of oral anticoagulants
* HIV positive with result of CD4 ≤ 200.
* Previously pelvic radiotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01941966
Study Brief:
Protocol Section:
NCT01941966