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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00026234
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed colorectal adenocarcinoma metastatic to the liver
* No extrahepatic metastases
* Prior complete surgical resection of hepatic metastases (at least 1 lesion) within the past 21-56 days
* Negative surgical margins unless surrounding normal liver tissue was ablated during surgery
* Radiofrequency ablation may be used as adjunct to surgical resection but not as primary treatment
* No prior operative ultrasound during resection of hepatic metastases
* Prior complete surgical resection of carcinoma of colon or rectum (must appear completely resectable in case of synchronous lesions)
* Performance status - ECOG 0-1
* Absolute neutrophil count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis)
* Creatinine no greater than ULN
* Creatinine clearance greater than 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Adequate oral nutrition (at least 1,500 calories/day)
* Able to withstand major operative procedure
* No dehydration
* No severe anorexia
* No frequent nausea or vomiting
* No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
* No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis
* No concurrent immunotherapy
* No concurrent colony-stimulating factors during the first course of study therapy
* No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan
* One prior 5-FU-based regimen as neoadjuvant treatment for rectal cancer is allowed
* No prior hepatic artery infusion therapy with 5-FU or floxuridine
* No prior systemic chemotherapy for metastatic disease
* No other concurrent chemotherapy
* No concurrent radiotherapy
* See Disease Characteristics
* No prior or concurrent sorivudine or brivudine
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00026234
Study Brief:
Protocol Section:
NCT00026234