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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00780169
Eligibility Criteria:
Inclusion Criteria:
* Metastatic colorectal cancer
* Histopathological verification of the primary tumor
* Measurable disease according to RESIST criteria
* Response Evaluation Criteria in Solid Tumors (ECOG) performance status ≤ 2
* Age \> 18 years.
* Women of childbearing potential must have had a negative pregnancy test within 7 days prior to start of treatment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Patients may have had prior adjuvant chemotherapy with fluoropyrimidines WITHOUT pelvic radiotherapy.
* Radiation: Patients may have had prior palliative radiation therapy to NO more than 50% of the areas bearing of bone marrow stores.
* Adequate organ and marrow function : Hemoglobin \> 9.0 g/dl; absolute neutrophil count (ANC) \>1,500/mm3; absolute granulocyte count(AGC) \> 1.5 x 109 /L; Platelets \> 100 x 109 /L; Serum creatinine and creatinine clearance within upper normal limit; Bilirubin \< 1.0 x upper normal limit, \< 2.5 x upper normal limit if documented liver metastases; aspartate aminotransferase (AST) \< 2.5 x upper normal limit, \< 5 x upper normal limit if documented liver metastases
* Life expectancy \> 3 months
* Informed consent
Exclusion Criteria:
* Previous or concurrent malignancies
* Patients with central nervous system (CNS) metastases
* Pregnant or lactating women
* Concurrent treatment with other experimental drugs or anticancer therapy
* Previous chemotherapy for advanced and/or metastatic disease
* Previous adjuvant therapy with irinotecan or targeted agents
* Previous Sorafenib therapy
* Previous full dose curative pelvic radiotherapy
* History of cardiovascular disease, cerebral ischemia infarction or hemorrhage, Gilbert's disease, HIV positivity
* Unable to be compliant with the procedures in the protocol
* Currently use prohibited medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00780169
Study Brief:
Protocol Section:
NCT00780169