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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT00506168
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic colorectal cancer
* ECOG performance status 0-2
* Mesurable lesions
* No prior chemotherapyk or radiotherapy for metastatic disease. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
* Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
* Adequate organ functions
* Expected survival is longer then 6 months
* Informed consent
Exclusion Criteria:
* Prior systemic chemotherapy for metastatic disease
* Prior treatment with oxaliplatin or irinotecan
* CNS metastases
* Uncontrolled or severe cardiovascular disease
* Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
* Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
* Psychiatric disorder or uncontrolled seizure that would preclude compliance
* Pregnant, nursing women or patients with reproductive potential without contraception
* Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al.
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
* Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00506168
Study Brief:
Protocol Section:
NCT00506168