Local Ablative Strategies After Endovascular Radioembolization

Stopped early · Phase 1

Conditions studied: Metastatic Colorectal Cancer

In brief

The rationale for this design is initial utilization of a standard-of-care therapy for mCRC (radioembolization) with a dose-calculation algorithm that has been verified as predictive for treatment response. Prediction of treatment failure will enable the proposed subsequent locoregional therapies which were selected based on safety profiles and feasibility. While the goal of this study is assessing feasibility and safety of this approach, the end goal of improving overall patient outcomes by improved hepatic tumor control.

Key facts

Study ID

NCT02611661

Run by

Washington University School of Medicine

People needed

9

Starts

2016-01-19

Expected to finish

2018-02-13

Last updated by the study team

2018-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of colorectal carcinoma with intrahepatic metastases; limited extrahepatic metastasis is allowed as long as the overall metastatic burden is hepatic dominant.
• Local surgical resection is not possible due to tumor or patient factors.
• Prior locoregional therapy is allowed if completed at least 2 weeks prior to enrollment.
• Prior chemotherapy is allowed if stopped/completed at least 2 weeks prior to enrollment.
• At least 18 years old.
• ECOG performance status ≤ 1.
• Scheduled to undergo radioembolization for treatment of intrahepatic metastases.
• Able to understand and willing to sign an IRB-approved written informed consent document.

You may not qualify if…

• Child-Pugh score 8 or greater.
• ALT or AST ≥ 6 x ULN.
• Prior history of abdominal irradiation. Patients who have received prior pelvic radiation for colorectal cancer are eligible; however, prior radiation treatment plans must be reviewed prior to enrollment.
• Presence of any contraindications to MRI scanning.
• GFR < 30 ml/min/1.73m2 (if receiving contrast for MRI).
• Currently on dialysis (if receiving contrast for MRI).
• Prior allergic reaction to gadolinium-based contrast agents (if receiving contrast for MRI).
• Pregnant or nursing. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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