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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT02465593
Eligibility Criteria:
Inclusion Criteria
* Histologically proven adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable disease , without evidence of distant metastases (M0)
* Distant border of the tumor must be located ≤ 10 cm from the anal verge
* Staging with MRI, transrectal ultrasound or CT-scan to confirm stage and resectability
* ECOG performance 0 - 1
* Age: 20 - 80 years old
* Adequate bone marrow, renal, and hepatic function as:
* absolute neutrophil count (ANC) ≥ 1,500/mm3
* platelet count ≥ 100,000/mm3
* total bilirubin ≤ 1.5x the upper limit of normal (ULN)
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN
* alkaline phosphatase (ALP) ≤ 2.5 x ULN
* calculated creatinine clearance ≥ 50 mL/min, or creatinine within normal range
* All female patients of childbearing potential must have negative urine pregnancy test within the 7 days prior study treatment with PEP503. Patients must agree to use effective contraception during the study
Exclusion Criteria:
* Prior history of pelvic radiation therapy
* Hypersensitivity to fluoropyrimidine
* Uncontrolled serious medical or psychiatric illness
* Myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months
* No more than 4 weeks since prior participation in any investigational drug study
* Major surgery within 28 days
* Other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
* Cardiovascular disease that would preclude study treatment or follow-up
* Informed consent not duly signed and dated to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02465593
Study Brief:
Protocol Section:
NCT02465593