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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT01317433
Eligibility Criteria:
Inclusion Criteria:
* Advanced or metastatic colorectal cancer, histologically confirmed, first or second metastatic line
* K-RAS wild-type
* Adjuvant prior chemotherapy allowed provided that all toxicities are grade \< or = 1 (excepted alopecia and neuropathy)
* Age between 18 and 80 years
* WHO Performance Status \< or = 2
* Complete initial assessment before first treatment administration for imaging and pharmacogenetic, within 15 days for biology, and within 7 days for clinical examination.
* Haematologic and hepatic parameters : neutrophils \> or = 1500 /mm3, platelets \> or = 100000/mm3, Total bilirubin \< or 2 x ULN, AST and ALT \< or = 3 x ULN, APL \< or = 5 x ULN
* Absence of total dihydropyrimidine dehydrogenase deficiency
* Patient able to comply with study requirements
* Signed written informed consent
Exclusion Criteria:
* History or presence of an other cancer, excepted cutaneous cancer (basocellular carcinoma), in situ cancer of the cervix or breast cancer curatively treated
* Any other concomitant anti-cancer therapy
* Prior anti EGFR therapy, anti angiogenic therapy is allowed
* Prior cyclines hypersensitivity
* Treatment with cyclines within 7 days before randomization
* Presence of a rash at randomization time
* Symptomatic or uncontrolled ventral nervous system metastases
* Total dihydropyrimidine dehydrogenase deficiency
* No recovery of any toxicity Grade \< or = 1 related to a past anticancerous treatment excepted for alopecia and neuropathy
* Active inflammatory bowel disease or other bowel
* Significant serious pathology or any unstable medical condition (cardiac pathology uncontrolled, myocardial infarction within 6 months before enrollment, systemic active uncontrolled infection)
* atropine contra-indication
* any investigational agent without marketing authorization within 4 weeks before enrollment
* Patient who is pregnant or breast feeding
* Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01317433
Study Brief:
Protocol Section:
NCT01317433