Colon Cancer Clinical Trial
Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.
age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
histologically confirmed primary adenocarcinoma of the colon or rectum
CLM considered unresectable or not amenable to percutaneous ablation
existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease.
adequate blood cell counts (WBC > 1.5 x 109/L, platelet count > 50 x 109/L)
adequate renal function (creatinine < 1.5 mg/dL)
total bilirubin level ≤ 1.5 mg/dL
Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:
A. patients not amenable to surgery or thermal ablation
Study exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:
prior hepatic radiotherapy (The lesion / lobe being treated cannot have had prior treatment with radiotherapy - untreated lesions / lobes in the liver may be evaluated under the protocol)
severe portal hypertension
uncorrectable flow to the gastrointestinal tract and/or >30 Gy (or >50 Gy in multiple sessions) radiation absorbed dose to the lungs
All patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.
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There is 1 Location for this study
New York New York, 10065, United States More Info
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