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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00075556
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed colorectal adenocarcinoma
* Clinical stage T3, T4, N+
* Measurable disease
* Awaiting surgery and likely to benefit from neoadjuvant radiotherapy
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN
* No hepatic condition that would interfere with study medication
Renal
* Creatinine clearance at least 80 mL/min
* No renal condition that would interfere with study medication
Cardiovascular
* No serious cardiac failure with the past year
* No myocardial infarction within the past year
* No cardiac insufficiency
* No angina
* No uncontrolled arrhythmia
* No uncontrolled hypertension
Gastrointestinal
* No superior intestinal tract malfunction
* No malabsorption syndrome
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent serious infection
* No other serious illness
* No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
* No metabolic condition that would interfere with study medication
* No dementia or altered mental status
* No psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for colorectal cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for colorectal cancer
Surgery
* Not specified
Other
* More than 30 days since prior participation in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00075556
Study Brief:
Protocol Section:
NCT00075556