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 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT00043004
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Unresectable liver metastases secondary to colorectal adenocarcinoma, including:
* Metastases that cannot be radically resected due to size, location, or number of deposits
* Metastases invading right and left branches of hepatic artery or portal vein
* Metastases extended to the 3 main hepatic veins
* No detectable extra-hepatic disease
* Fewer than 10 metastatic deposits on liver
* Total metastatic involvement of liver no more than 50%
* Adequate treatment of all metastatic lesions deemed possible either by radiofrequency interstitial ablation (RFA) alone or by a combination of resection of resectable lesions and RFA of the remaining unresectable lesions
* Maximum diameter of 4 cm for lesions to be treated with RFA
* No maximum diameter of lesions to be resected as long as negative resection margins are obtainable
* If synchronous liver metastases, must have undergone prior resection of primary tumor
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* No bleeding disorder or coagulopathy or need for full-dose anticoagulation
Hepatic
* Bilirubin less than 3 times upper limit of normal (ULN)
* Alkaline phosphatase less than 3 times ULN
Renal
* Creatinine less than 2 times ULN
* Protein \< 0.5 g/24 hr urine collection if proteinuria positive by dipstick
Cardiovascular
* No uncontrolled congestive heart failure
* No uncontrolled angina pectoris
* No uncontrolled hypertension
* No uncontrolled arrhythmia
* No myocardial infarction within the past 12 months
* No cerebrovascular accident or transient ischemic attack within the past 6 months
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No greater than grade 1 peripheral neuropathy
* No significant neurologic or psychiatric disorder
* No active infection
* No contraindication to the use of fluorouracil, leucovorin calcium, oxaliplatin, or bevacizumab
* No other malignancy within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy except for metastatic disease confined to the liver
* Prior fluorouracil, leucovorin calcium, and oxaliplatin allowed if administered for at least 3 courses (2 weeks each) but no longer than 3 months with at least stabilization of disease achieved
* Prior adjuvant chemotherapy for primary cancer allowed except for patients who received oxaliplatin and have been diagnosed with metastatic disease within 12 months after completion of adjuvant treatment
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* More than 28 days since major surgery or open biopsy past 28 days
* More than 28 days since significant traumatic injury
Other
* No other concurrent investigational treatment
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00043004
Study Brief:
Protocol Section:
NCT00043004