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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01189227
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal adenocarcinoma
* Hepatic metastasis (no histologic confirmation required) and no evidence of extrahepatic metastatic disease within the past 4 weeks by one of the following imaging studies\*:
* PET/CT scan with contrast
* PET scan AND CT scan with contrast
* PET scan AND MRI with contrast
* PET/CT scan without contrast AND MRI with contrast NOTE: \*If findings noted in imaging study reports are equivocal, the determination of whether or not the findings represent extrahepatic disease will be at the investigator's discretion.
* No history of or concurrent evidence of extrahepatic metastases
* Patients with regional nodes that are suspicious on imaging and are associated with the primary colorectal tumor are eligible provided the nodes will be resected with the primary tumor after randomization
* No radiographic evidence of metastases to portal lymph nodes (node \> 1 cm in diameter) unless the node(s) are proven by biopsy to be negative
* No anal, small bowel, or appendiceal carcinoma
* No sarcoma, lymphoma, or carcinoid colorectal malignant diseases
* Within 4 weeks before randomization, the liver metastases must be determined by a hepatic surgeon to be resectable based on meeting both of the following criteria:
* A complete resection can be performed in a single operation
* There are ≥ 2 uninvolved contiguous segments of the liver
* Meets one of the following criteria:
* Primary tumor and regional nodes resected with clear surgical margins and no evidence of extrahepatic disease
* Unresected primary tumor with plans to resect the primary tumor before randomization
* Unresected primary tumor with plans to resect the primary tumor and the liver metastases in a single surgical procedure performed after randomization
* No unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiotherapy
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy ≥ 5 years (excluding the diagnosis of metastatic CRC)
* absolute neutrophil count (ANC) ≥ 1,200/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Total bilirubin ≤ upper limit of normal (ULN)
* aspartate aminotransferase (AST) ≤ 5.0 times ULN
* Alkaline phosphatase ≤ 5.0 times ULN
* Serum creatinine ≤ ULN OR calculated creatinine clearance ≥ 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 180 days after completion of study treatment
* Considered a potential candidate for a major hepatic surgical procedure
* No grade 3 or 4 anorexia, grade 3 nausea, or vomiting ≥ grade 2 (per CTCAE v4.0) related to metastatic disease
* No paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy ≥ grade 2 per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 (patients with grade 2 neuropathy who will receive FOLFIRI are eligible)
* No uncontrolled high BP defined as systolic BP ≥ 160 mm Hg OR diastolic BP ≥ 100 mm Hg, with or without antihypertensive medication (patients with initial BP elevations are eligible provided initiation or adjustment of BP medication lowers pressure to meet this criteria)
* Documented history of congestive heart failure requiring chronic medical therapy
* No active inflammatory bowel disease
* No active infection or chronic infection requiring chronic suppressive antibiotics
* No known bleeding diathesis or coagulopathy
* No symptomatic interstitial pneumonitis OR definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray in asymptomatic patients
* No other malignancies unless the patient is considered to be disease-free and has completed therapy for the malignancy ≥ 1 year ago
* Patients with carcinoma in situ of the cervix, CRC in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin diagnosed and treated at any time before study treatment are eligible
* No known Gilbert syndrome
* Not known to be homozygous for the UGT1A1 allele (for patients who will receive FOLFIRI chemotherapy)
* No prior serious hypersensitivity reaction to any of the agents administered as part of study treatment (determination of "serious" is at the investigator's discretion)
* No other serious concurrent medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization
* No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
* No pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No previous hepatic-directed therapy, including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiotherapy
* Patients who have only had an incision or excisional biopsy are eligible
* No previous chemotherapy or any other systemic therapy for metastatic colorectal cancer (CRC)
* No prior or concurrent portal vein embolization or other hepatic preconditioning techniques
* At least 30 days since prior investigational products
* No intent to use ablation to treat any hepatic lesion
* No concurrent therapeutic doses of coumadin or equivalent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01189227
Study Brief:
Protocol Section:
NCT01189227