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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT03426904
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed colon adenocarcinoma (\> 15 cm from the anal verge)
* Radiologic T3/T4 and high risk features by CT scan
* No metastasis on CT or PET(positron emission computed tomography)
* Age ≥ 18 and ≤ 70 years
* ECOG (Eastern Cooperative Oncology Group) performance status 0-1
* No history of colorectal cancer within 5 years
* No history of chemotherapy
* Patients with childbearing potential should use effective contraception during the study and the following 6 months
* Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more
* Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less
* Adequate renal function : GFR (Glomerular Filtration Rate) \> 50ml/min by Wright or Cockcroft formula
* Signed written informed consent obtained prior to any study specific screening procedures
Exclusion Criteria:
* Age \> 70 years and \< 18 years
* Rectal cancer : 15 cm or less from the anal verge
* Complicated colon cancer (complete obstruction, perforation, bleeding)
* Metastatic colon cancer
* Known hypersensitivity reaction to any of the components of study treatments
* Inflammatory bowel disease
* Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
* Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
* Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Pregnancy or breast-feeding period
* Serious non-healing wound or bone fracture
* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
* Any significant disease which, in the investigator's opinion, would exclude the patient from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03426904
Study Brief:
Protocol Section:
NCT03426904