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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT00611858
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the rectum that begins within 15cm of the anal verge as determined by sigmoidoscopy and/or colonoscopy, with no evidence of distant metastatic disease. A complete colonoscopy to the cecum is recommended prior to initiating protocol therapy.
* Staging with transrectal ultrasound or endorectal coil Magnetic resonance imaging (MRI) to confirm clinical stage of T3 or T4 or lymph node positive rectal adenocarcinoma
* Tumor is K-ras wildtype by method of choice at respective institution (testing codons 12 and 13)
* Performance status: Eastern Cooperative Oncology Group Performance Score (ECOG PS) less than or equal to 2
* 18 years of age or older
* No evidence of metastatic disease by abdominal/pelvic (Computed tomography) CT and chest imaging
* Adequate bone marrow, renal,and hepatic function as outlined in protocol
* All patients will be evaluated by a surgeon and considered a candidate for definitive surgery
* Coumadin or heparin management for line care of other indications is permitted. The International Normalised Ratio (INR) will be monitored weekly in patients taking coumadin.
Exclusion Criteria:
* Prior treatment for this malignancy
* Prior history of pelvic radiation therapy
* Prior history of 5-FU based or EGFR receptor inhibitor therapy
* Prior history of an allergic reaction to a monoclonal antibody
* Uncontrolled serious medical or psychiatric illness
* Significant history of uncontrolled cardiac disease
* Sexually active women of childbearing potential must use an effective method of birth control during the course of the study
* Unwilling to agree to pre and post-cetuximab sigmoidoscopy and biopsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00611858
Study Brief:
Protocol Section:
NCT00611858