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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00126256
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic colorectal adenocarcinoma
* Unresectable metastasis
* Bidimensionally measurable disease (World Health Organization \[WHO\] criteria)
* WHO performance status of 2 or less
* Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; and platelet count, at least 100,000 per cubic millimetre)
* Adequate renal function (serum creatinine, less than 125 micromol per liter)
* Adequate liver function (bilirubin, not more than 5 times the upper limit of normal)
* No previous chemotherapy other than previous adjuvant chemotherapy or concomitant chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary tumor completed at least 6 months before inclusion
* Signed written inform consent
* Quality of life questionnaire (QLQ C-30) filled out
Exclusion Criteria:
* Pregnant or breast - feeding women
* Impossibility of regular follow-up for psychological, social or geographical reason
* Severe cardiac, respiratory, renal or hepatic failure
* Active coronary heart disease
* Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
* Central nervous system metastases
* Past history of second malignancies
* Another investigational drug
* Chronic inflammatory bowel disease
* Previous chemotherapy with irinotecan or oxaliplatin based regimens
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00126256
Study Brief:
Protocol Section:
NCT00126256