Local Ablative Strategies After Endovascular Radioembolization (LASER)
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Other
Experimental
Experimental
Experimental
No Intervention
Stratum 1: Observe
Stratum 2: Percutaneous ablation
Stratum 3: SBRT
Stratum 4: SBRT + Percutaneous Ablation
Stratum 5: Referral for systemic therapy
PET/MRI within 36 hours of standard of care hepatic radioembolization received off study No further treatment just observation
PET/MRI within 36 hours of standard of care hepatic radioembolization received off study Percutaneous ablation can be radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, and irreversible electroporation
PET/MRI within 36 hours of standard of care hepatic radioembolization received off study The planned SBRT dose will be 30 Gy in 5 fractions of 6 Gy each. It is recommended that each fraction be separated by a minimum of 12 hours and a maximum of 8 days.
PET/MRI within 36 hours of standard of care hepatic radioembolization received off study Percutaneous ablation can be radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, and irreversible electroporation The planned SBRT dose will be 30 Gy in 5 fractions of 6 Gy each. It is recommended that each fraction be separated by a minimum of 12 hours and a maximum of 8 days.
PET/MRI within 36 hours of standard of care hepatic radioembolization received off study Referred for further systemic therapy and are not candidates for further locoregional therapy on study.