Combining total ablative therapy with standard treatment for limited metastatic colorectal cancer
Official title: A Pragmatic Randomized Phase II Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)
Run by Alliance for Clinical Trials in Oncology · NCT05673148 · Data updated 2026-11-12
This study is testing if adding a special type of radiation therapy and possible surgery to standard chemotherapy can help people with limited metastatic colorectal cancer live longer and stay healthier.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 195 sites (Kingman, Arizona and 194 other locations) |
| Status | Recruiting |
| Started | October 9, 2023 |
| Main results expected | July 3, 2028 |
| Study ends | August 12, 2032 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT05673148 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with newly diagnosed oligometastatic colorectal adenocarcinoma who have a resectable primary tumor and no known MSI or BRAF V600E mutations.
✕Probably not a fit
Patients with unresectable primary tumors or those with peritoneal and/or omental metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III trial investigates the effectiveness of adding total ablative therapy to the usual systemic therapy for patients with limited metastatic colorectal cancer. Participants are randomized into two groups: one receiving standard systemic chemotherapy along with stereotactic ablative radiotherapy (SABR) and possibly surgical resection or microwave ablation, and the other receiving only standard systemic chemotherapy. The study aims to evaluate overall survival, event-free survival, and the safety profile of the treatments. Imaging studies will be conducted throughout the trial to monitor progress.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with limited metastatic colorectal cancer.
How similar studies have gone: Previous studies have shown promise with similar ablative approaches, but this specific combination is being tested for the first time in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
* PRE-REGISTRATION (STEP 0): Pathologically proven diagnosis of metastatic colorectal adenocarcinoma with metastases (biopsy from primary tumor or metastatic site is acceptable)
* PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
* PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
* PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
* PRE-REGISTRATION (STEP 0): Liver-only metastatic disease on baseline imaging prior to starting chemotherapy is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver on initial imaging to be eligible for this study. Of note, patients who have metastatic disease to the liver and at least one other site on initial imaging who have liver-only metastatic disease on subsequent imaging after completing initial systemic therapy are eligible
* PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
* REGISTRATION (STEP 1): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* REGISTRATION (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* REGISTRATION (STEP 1): A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration
* REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined
* REGISTRATION (STEP 1): Primary tumor is already resected OR patient has had a clinical complete response without surgical resection and no local regrowth (primary rectal tumors only) OR primary tumor is amenable to surgical resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
* REGISTRATION (STEP 1): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of radiographic imaging obtained following at least 12 weeks of systemic therapy. Of note, the primary tumor and associated regional lymph nodes do not count as one of the sites of disease.
* Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.
* Metastatic lesions must be amenable to surgical resection, microwave ablation, radiationSABR or any combination of these modalities.
* Subcentimeter indeterminate lesions such as lung nodules \< 5 mm in size may be considered metastases unless there are \> 2 months of documented stability prior to the initiation of systemic
* Single sites include:
* Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field.
* REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1
* REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 12 weeks and a maximum of 52 weeks
* REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 6 months prior to diagnosis of metastatic disease
* REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.
\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
* REGISTRATION (STEP 1): Age \>= 18 years
* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \>= 1,000/mm\^3
* REGISTRATION (STEP 1): Platelet count \>= 50,000/mm\^3
* REGISTRATION (STEP 1): Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 30 mL/min
\* Calculated using the Cockcroft-Gault equation
* REGISTRATION (STEP 1): Total bilirubin =\< 1.5 x ULN
\* If Gilbert's disease, use direct bilirubin instead of total bilirubin; direct bilirubin =\< 1.5 ULN if patient to receive FOLFIRI (leucovorin calcium, 5-fluorouracil, and irinotecan); direct bilirubin ≤ 3.0 x ULN if patient to receive mFOLFOX6 (leucovorin calcium, 5-fluorouracil, and oxaliplatin)
* REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x ULN
\* In the event of metastatic liver disease, =\< 5 x ULN
* REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility
* REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study
Exclusion Criteria:
* N/A
Where it's running
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Kingman Regional Medical Center
Kingman, Arizona, United States Recruiting -
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States Recruiting -
Tower Cancer Research Foundation
Beverly Hills, California, United States Recruiting -
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States Recruiting -
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States Recruiting
Show 44 more locations
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Beebe Medical Center
Lewes, Delaware, United States Recruiting -
Beebe South Coastal Health Campus
Millville, Delaware, United States Recruiting -
Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Recruiting -
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States Recruiting -
Beebe Health Campus
Rehoboth Beach, Delaware, United States Recruiting -
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States Recruiting -
George Washington University Medical Center
Washington D.C., District of Columbia, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States Recruiting -
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States Recruiting -
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States Recruiting -
Grady Health System
Atlanta, Georgia, United States Recruiting -
Emory Proton Therapy Center
Atlanta, Georgia, United States Recruiting -
Emory University Hospital Midtown
Atlanta, Georgia, United States Recruiting -
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States Recruiting -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Recruiting -
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States Recruiting -
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States Recruiting -
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States Recruiting -
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States Recruiting -
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States Recruiting -
University of Illinois
Chicago, Illinois, United States Recruiting -
Baptist Health Floyd
New Albany, Indiana, United States Recruiting -
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States Recruiting -
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States Recruiting -
Mercy Cancer Center-West Lakes
Clive, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States Recruiting -
Iowa Methodist Medical Center
Des Moines, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States Recruiting -
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States Recruiting -
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States Recruiting -
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States Recruiting -
Baptist Health Louisville
Louisville, Kentucky, United States Recruiting -
University Medical Center New Orleans
New Orleans, Louisiana, United States Recruiting -
Boston Medical Center
Boston, Massachusetts, United States Recruiting -
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States Recruiting
+145 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Eric D. Miller, MD, PhD
- Email: eric.miller@osumc.edu
- Phone: 614-685-4922
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.