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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01633203
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven invasive carcinoma
* Age \> 18 years.
* ECOG performance status 0 or 1.
* Hemoglobin \> 9 g/dL
* Absolute neutrophil count \> 1.5 x 109/L
* Platelet count \> 100 x 109/L
* Creatinine \< 1.5 ULN
* Creatinine clearance \> 60 mL/min
* Serum bilirubin \< 1.5 x ULN
* AST \< 2.5 x ULN
* Women of child bearing potential: must agree to use an effective contraceptive method.
* Signed informed consent.
Exclusion Criteria:
* ECOG \> 2.
* Pre-existing diarrhea uncontrolled with supportive care.
* Inability to swallow Xeloda tablets.
* History of mild-to-moderate renal insufficiency (creatinine clearance \< 45 mL/min).
* Signs or symptoms of clinically significant hepatic dysfunction (bilirubin \> 1.5 ULN, FA \> 2.5 ULN, albumin \< 2,5 g/dL).
* Significant cardiac dysfunction (LVEF \< LLN)
* Presence of distant metastasis, including clinical signs of peritoneal carcinomatosis
* Symptomatic gastric retention or severe dysphagia with a caloric intake of \< 1500 kcal/day
* Histology of lymphoma, GIST or neuroendocrine tumor
* Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use an effective method of contraception.
* Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parental or oral treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT01633203
Study Brief:
Protocol Section:
NCT01633203