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 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT00046995
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon
* Stage IIB or III (Dukes stage B2 or C)
* Complete curative resection performed within the past 7 weeks (negative margins)
* No local or regional relapsed disease
* Tumor more than 15 cm above the anal margin
* Carcinoembryonic antigen less than 5 ng/mL (after surgery)
* No rectal cancer
* No metastatic disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1 OR
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No serious coronary disease
Other
* Not pregnant
* Fertile patients must use effective contraception
* No concurrent infectious disease
* No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy (before or after surgery)
Surgery
* See Disease Characteristics
Other
* No concurrent participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00046995
Study Brief:
Protocol Section:
NCT00046995