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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00408551
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed colorectal cancer\* meeting 1 of the following criteria:
* Metachronous metastasis after resection of Dukes A-C (i.e., stage I-III) primary colon cancer with or without adjuvant chemotherapy
* Metachronous metastasis after resection of primary rectal cancer with neoadjuvant or adjuvant chemotherapy
* Synchronous metastatic liver disease with symptomatic or asymptomatic primary colorectal cancer NOTE: \*If the patient has a second malignancy with liver metastasis potential, histologic or cytologic confirmation of the liver lesions may be performed as clinically indicated
* Liver-only or liver-predominant disease with any of the following:
* Unresected primary disease
* Limited bone or lung disease
* Potentially resectable nodal disease
* Anastomotic disease
* No active CNS metastasis or diffuse peritoneal metastasis
* No hepatic metastases from a second malignancy
* No predominant extrahepatic disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* WBC ≥ 1,500/mm\^3
* Creatinine ≤ 2 mg/dL
* Bilirubin ≤ 2 mg/dL (without extrahepatic biliary obstruction)
* Albumin \> 2 g/dL
* INR \< 1.5 (without anticoagulation)
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior external-beam radiotherapy to the liver
* Concurrent targeted therapy agents (e.g., bevacizumab or cetuximab) allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00408551
Study Brief:
Protocol Section:
NCT00408551