Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 9, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how a treatment called radioembolization affects tumor cells in patients with various types of colon cancer that have spread to the liver. Researchers will take biopsy samples from the tumors after the procedure to better understand how the treatment works and how it can be improved. This study aims to help doctors provide better care for patients whose cancer has spread and may uncover important information about how tumors respond to this specific treatment.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of colon or rectal cancer that cannot be surgically removed. They should also be in reasonably good health, with adequate blood counts and kidney function. Participants can expect to undergo the radioembolization procedure, followed by a biopsy of their tumor. This research is currently recruiting patients of all genders, and it’s important to note that those with certain liver conditions or prior treatments may not be eligible. Overall, this trial represents an opportunity to contribute to important cancer research that could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• 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 cirrhosis
• • 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.