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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01024504
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
* Stage IV
* Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
* Absence or irradiated and stable central nervous system metastatic disease.
* Life expectancy of more than 3 months.
* Age ≥ 70 years.
* Performance status (WHO) ≤ 2.
* Adequate bone marrow function (Absolute neutrophil count \>1000/mm3, Platelet count \>100000/mm3, Hemoglobin \>9gr/mm3).
* Adequate liver (Bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal).
* Creatinine clearance (Cockcroft-Gault formula) \>30ml/min.
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
* Presence of a reliable care giver.
* Informed consent.
Exclusion Criteria:
* Prior chemotherapy for metastatic disease.
* History of thromboembolic disease or myocardial infraction within the last 6 months.
* Peripheral neuropathy ≥ grade 2.
* Bowel obstruction or chronic diarrhea.
* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other concurrent investigational agents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01024504
Study Brief:
Protocol Section:
NCT01024504