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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT00686166
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Biopsy-proven primary adenocarcinoma of the rectum
* Stage II or III disease
* The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of the anal verge by proctoscopic examination
* No recurrent disease
* Must have wild-type k-ras status
* Measurable and/or nonmeasurable disease
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* Leukocyte count ≥ 3,000/mcL
* Granulocyte count ≥ 1,500/mcL
* Platelet count ≥ 100,000/mcL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase)≤ 2.5 times ULN
* Creatinine clearance \> 50 mL/min
* No prior severe reaction to a monoclonal antibody
* Willing to have specimens submitted
* No peripheral neuropathy ≥ grade 2
* No known existing uncontrolled coagulopathy
* No evidence of current high-grade obstruction
* At least 2 weeks since prior diverting procedure
* No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol treatment
* No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil or known DPD deficiency
* No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow that would impair the ingestion or absorption of capecitabine
* No uncontrolled intercurrent illness
* No ongoing or active infection
* No symptomatic congestive heart failure or unstable angina pectoris
* No cardiac arrhythmia or myocardial infarction within the past 12 months
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
* Recovered from any recent major surgeries (e.g., coronary artery bypass graft, transurethral resection of prostate, or abdominal surgery)
* No prior chemotherapy, radiotherapy, or targeted therapy for this tumor
* More than 4 weeks since prior investigational agents
* No concurrent anti-retroviral therapy for HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00686166
Study Brief:
Protocol Section:
NCT00686166