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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT01338558
Eligibility Criteria:
Inclusion Criteria:
* Adult patients \>/= 18 years of age
* Histologically confirmed adenocarcinoma of the colon or rectum
* Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
* Tumour tissue sample available for assessment of K-RAS and BRAF genes
* Prior radiotherapy must have been completed 4 weeks before randomization
* Adequate bone marrow, kidney and liver function
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria:
* Previous chemotherapy for metastatic disease
* Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
* Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
* Clinical or radiographic evidence of brain metastases
* Clinically significant cardiovascular disease or disorder
* History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
* HIV, hepatitis B or C infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01338558
Study Brief:
Protocol Section:
NCT01338558