Biopsy to study tumor changes after radioembolization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: sofoclec@mskcc.org
• Phone: 212-639-3379

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.