Kathryn Hitchcock, MD, PhD, radiation oncologist, University of Florida Health, assistant professor, University of Florida, expands on potential clinical implications of the ongoing phase 3 ERAsur trial (NCT05673148) in metastatic colorectal cancer (mCRC).

The pragmatic, randomized trial is evaluating the use of total ablative therapy vs standard-of-care systemic therapy alone in patients with limited mCRC who are not candidates for resection or who have additional disease sites in the liver or lungs. Patients treated with total ablative therapy will receive any combination of stereotactic body radiation therapy with or without surgery and/or microwave ablation at all metastatic sites. Those given systemic therapy may receive physician’s choice of additional first-line systemic therapy, maintenance chemotherapy, or a pause in treatment.

The trial is currently open to enrollment at all National Clinical Trials Network sites in the United States, Hitchcock states. Fine points of the trial are still under consideration and open for potential adjustment, Hitchcock notes.

The goal of the trial is to inform the optimal use of local ablative therapy in this population, Hitchcock says. Previously reported retrospective data demonstrated an association between increased long-term overall survival (OS) and the application of aggressive local therapy to isolated metastases for patients with oligometastatic colorectal cancer. However, the ability of this approach to improve survival outcomes, cure rates, and longevity for patients with limited mCRC has been underresearched in a formal, randomized controlled setting, Hitchcock explains. In the event that findings are negative, the high cost and toxicities associated with total ablative therapy may render this approach ill-suited for patients with limited mCRC, she adds.

Additionally, data on circulating tumor DNA (ctDNA) levels will also be collected in the study, Hitchcock notes. These data may expand current understanding of the relationship between ctDNA and patient responses in CRC before, during, and after treatment, Hitchcock concludes.

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Kathryn Hitchcock, MD, PhD, expands on potential clinical implications of the ongoing phase 3 ERAsur trial in metastatic colorectal cancer

Dr Hitchcock on Potential Clinical Implications of the ERAsur Trial in Limited mCRC

Kathryn Hitchcock, MD, PhD, radiation oncologist, University of Florida Health, assistant professor, University of Florida, discusses the rationale for the ongoing phase 3 ERAsur trial (NCT05673148) investigating total ablative therapy in patients with limited metastatic colorectal cancer (mCRC) and details the methodologies being used in this study.

Until recently, patients with metastatic CRC would receive chemotherapy and likely continue with that treatment until the end of their lives, Hitchcock begins. However, some patients with metastatic disease could potentially be curable, she says, adding that curative-intent approaches are currently being pursued in patients with metastatic disease who present with only a few metastases. However, there have been no formal, randomized, prospective studies that have looked at approaches such as total ablative therapy within this setting for this patient population, Hitchcock explains.

ERAsur is enrolling patients with histologically confirmed mCRC who do not have microsatellite instability, 

 V600E mutations, or known peritoneal disease. Patients need to have a primary tumor that have been resected or is resectable, and they are required to have 4 or fewer metastatic sites. Patients are being randomly assigned to total ablative therapy in addition to standard-of-care systemic therapy or standard-of-care systemic therapy alone.

Prior to randomization, all patients will first receive up-front systemic therapy for 4 to 6 months, Hitchcock says. Those who experience disease progression during this time will be removed from trial protocol.Remaining patients will be randomly assigned to 1 of the 2 treatment arms. In the experimental arm, patients will be allowed to receive any combination of local therapies that could benefit them, in the opinion of the treating physician, Hitchcock continues. Notably, patients are permitted to receive additional chemotherapy following localized treatment, Hitchcock says.

Treatment will continue until disease progression, and all patients will be followed until death, Hitchcock adds. Overall survival is the primary end point, and secondary end points include event-free survival, safety, and time to local recurrence. Notably, patients initially assigned to the control arm will be allowed to receive localized treatment following disease progression, Hitchcock concludes.

Kathryn Hitchcock, MD, PhD, discusses the rationale for the ongoing phase 3 ERAsur trial investigating total ablative therapy in patients with limited metastatic colorectal cancer and details the methodologies being used in this study.


Kathryn Hitchcock, MD, PhD

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Dr Hitchcock on Potential Clinical Implications of the ERAsur Trial in Limited mCRC

Dr Hitchcock on the Rationale for the ERAsur Trial in Limited mCRC