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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT03069950
Eligibility Criteria:
Inclusion Criteria:
* History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Confirmation of diagnosis must be performed by the enrolling institution.
* Patients must have a primary L sided colorectal cancer, (at or distal to the splenic flexure)
* Confirmed RAS/RAF wild type tumor. Paraffin-embedded tumor tissue obtained from the primary tumor or metastasis
* Have received prior treatment for metastatic disease with oxaliplatin-based regimen and either
* Had disease progression OR
* Had stable disease OR
* Discontinued oxaliplatin due to neuropathy
* Patients must meet the following criteria for unresectability as determined by two hepatobiliary surgeons and one radiologist:
* When a margin negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava.
* Requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage. \*\*
\*\*A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments.
* Patient"s liver metastases must comprise \<70% of the liver parenchyma. All patients must be clinically fit to undergo surgery as determined by the pre-operative evaluation
* Lab values within 14 days prior to enrollment/randomization:
* WBC ≥ 3.0 K/uL
* ANC \> 1.5 K/uL
* Platelets ≥ 100,000/uL
* Renal function (≤ 10 days prior to enrollment/randomization) °Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method as follows:
Cockcroft-Gault method as follows:
* Male creatinine clearance = (140 -age in years) x (weight in Kg) / (serum Cr in mg/dl x 72)
* Female creatinine clearance = (140 - age in years) x (weight in Kg) x 0.85 / (serum Cr in mg/dl x 72) (use of creatinine clearance per protocol based on chemotherapy regimen)
* Hepatic function, as follows: (≤ 10 days prior to enrollment/randomization)
* Total Bilirubin ≤ 1.5 mg/dl
* Calcium ≥ lower limit of normal (≤ 48 hours prior to enrollment/randomization)
* KPS ≥ 60% (ECOG (or Karnofsky) performance status (preferably 0 or 1/≥ 60% for Karnofsky))
Exclusion Criteria:
* Patients \< 18 years of age
* Patients who have received more than one chemotherapy regimen for metastatic disease
* Patients who are chemotherapy naïve
* Prior radiation to the liver (Prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration)
* Active infection
°Active infection includes patients with positive blood cultures
* Prior treatment with HAI FUDR
* Prior TACE
* Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤ 72 hours before enrollment and randomization, and must have a negative pregnancy test ≤ 72 hours prior to treatment start)
* If a patient has any serious medical problems which may preclude receiving this type of treatment
* Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded.
* Serious or non-healing active wound, ulcer, or bone fracture
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
* Patients who have a diagnosis of Gilbert"s disease
* History of other malignancy, except:
1. Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician
2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
3. Adequately treated cervical carcinoma in situ without evidence of disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03069950
Study Brief:
Protocol Section:
NCT03069950