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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT00063960
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic colorectal adenocarcinoma
* Primary colorectal adenocarcinoma that has been completely resected (R0 disease)
* No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast
* Metastatic disease
* No more than 9 liver metastases
* All lesions completely resected or completely treated by ablation (with or without resection)
* All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava
* All resected lesions must have a negative surgical margin (R0)
* Disease progression after prior systemic irinotecan for metastatic disease allowed
* No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection
* No other prior resection of extrahepatic metastases
* Must have the entire liver remnant perfused with a single catheter
* Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2 mg/dL
* Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN)
* AST and ALT no greater than 2.0 times ULN
* No active hepatitis B or C infection
* No histological evidence of cirrhosis
Renal
* Creatinine no greater than 1.5 times ULN
* Calcium less than 1.3 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile
* Medically fit to begin chemotherapy between 4 and 8 weeks after surgery
* Prior cancer allowed if all of the following criteria are met:
* Undergone potentially curative therapy for all prior malignancies
* No other malignancy within the past 5 years except the following:
* Effectively treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix that has been effectively treated by surgery alone
* Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone
* No evidence of recurrence of any prior malignancy
* No prior hepatic arterial infusion pump malfunction, malperfusion, or infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunologic or biologic therapy
Chemotherapy
* No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection)
* No prior hepatic arterial infusion with fluorouracil or floxuridine
Radiotherapy
* No concurrent adjuvant radiotherapy to the pelvis
* No other concurrent radiotherapy
Other
* No other concurrent systemic therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00063960
Study Brief:
Protocol Section:
NCT00063960