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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT00749450
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of colorectal cancer meeting 1 of the following criteria:
* High-risk stage IIB disease, defined as T4 disease, perforation, obstruction, \< 10 nodes examined, poorly differentiated histology, extramural venous invasion, or extramural lymphatic invasion
* Fully resected stage III disease
* Patients with rectal cancer must meet the following criteria:
* Underwent prior total mesorectal excision surgery with negative resection (R0) margins
* No prior pre-operative or scheduled post-operative combined chemotherapy and radiotherapy
* No evidence of residual or metastatic disease
* Deemed suitable for adjuvant chemotherapy
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Life expectancy \> 5 years with reference to noncancer-related diseases
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* AST and ALT ≤ 2.5 times upper limit of normal
* Carcinoembryonic antigen (CEA) levels normal
* Glomerular filtration rate ≥ 30 mL/min (no moderate or severe renal impairment)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must effective contraception
* More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:
* Cerebrovascular accident
* Myocardial infarction
* Unstable angina
* New York Heart Association class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg)
* Disease-free interval of ≥ 5 years for previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal cell or squamous cell carcinoma of the skin
* No known or suspected dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 10 weeks since prior surgery and recovered
* No prior chemotherapy (except in patients randomized after 12 weeks of adjuvant therapy)
* No prior abdomino-pelvic radiotherapy, with the exception of short-course pre-operative radiotherapy for rectal cancer
* No concurrent brivudine or sorivudine for patients taking capecitabine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00749450
Study Brief:
Protocol Section:
NCT00749450