Biopsy to study tumor changes after radioembolization

Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study

This study is trying to see how tumors in patients with colorectal cancer that has spread to the liver change after they receive a specific radiation treatment called radioembolization.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT04668872 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect biopsy samples from tumors of patients with colorectal cancer that has spread to the liver after undergoing radioembolization treatment. By analyzing these samples, researchers hope to understand how the tumors respond to the radiation therapy and improve the procedure's effectiveness. The study focuses on patients with unresectable liver metastases from adenocarcinoma of the colon or rectum, and it includes specific eligibility criteria to ensure appropriate patient selection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable colorectal liver metastases and adequate health status.

Not a fit: Patients with prior hepatic radiotherapy or those whose tumors are amenable to surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness of radioembolization for patients with liver metastases from colorectal cancer.

How similar studies have performed: While this approach is novel in its specific focus on biopsy analysis post-radioembolization, similar studies have shown promise in understanding tumor responses to radiation therapies.

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.

Where this trial is running

New York, New York

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Constantinos T Sofocleous, MD, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Constantinos T Sofocleous, MD, PhD

Conditions: Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Liver Metastasis Colon Cancer, Colorectal Cancer, colorectal liver metastases, transarterial radioembolization