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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT00004150
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon
* Must have had curative radical resection within 56 days prior to study
* No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10.0 g/dL
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No severe coronary heart disease
* No New York Heart Association class III or IV heart failure
Other:
* No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No uncontrolled infection
* No other severe disease
* No known allergy to leucovorin calcium
* No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis
* No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer)
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for colon cancer
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for colon cancer
Surgery:
* See Disease Characteristics
Other:
* No other concurrent systemic anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004150
Study Brief:
Protocol Section:
NCT00004150