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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00557102
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon or rectum
* Must have synchronous or metasynchronous unresectable hepatic metastases
* Less than 8 hepatic metastases
* Less than 6 segments of liver involvement with metastases
* No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases
* Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible
* At least 1 measurable metastasis by CT scan or MRI
* No brain metastases, bone metastases, or carcinomatous meningitis
* No celiac lymph node involvement or peritoneal cancer
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* PT rate \> 70%
* Bilirubin \< 30 μmol/L
* Creatinine \< 130 μmol/L
* Creatinine clearance \> 60 mL/min
* Not pregnant or nursing
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No severe unstable angina
* No symptomatic heart failure
* No other concurrent illness
PRIOR CONCURRENT THERAPY:
* At least 3 months since prior adjuvant anticancer chemotherapy
* No concurrent participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00557102
Study Brief:
Protocol Section:
NCT00557102