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:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT00755534
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed locally advanced or metastatic colorectal cancer
* Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
* ECOG performance status ≤ 2
* Age 18 - 72 years
* Patients who have had a CR, PR or SD after 1st line therapy based on Irinotecan+Bevacizumab
* Paraffin block from the primary tumor in order to perform tha mutational analysis of the KRAS gene
* Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
* Patients must be able to understand the nature of this study
* Written informed consent
Exclusion Criteria:
* Presence of central nervous system or brain metastases
* Pregnant or lactating woman
* Life expectancy \< 3 months
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow or in the field where the treatment target is located
* Peripheral neuropathy grade ≥2
* Known hypersensitivity to Erbitux
* Metastatic infiltration of the liver \>50%
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
* Active infection
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Psychiatric illness or social situation that would preclude study compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
72 Years
Study:
NCT00755534
Study Brief:
Protocol Section:
NCT00755534