Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial

Active:	Yes
Cancer Type:	Colon/Rectal Cancer	NCT ID:	NCT05673148
Trial Phases:	Phase III	Protocol IDs:	A022101 (primary) A022101 NCI-2022-09253
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT05673148

Summary

This phase III trial compares the addition of total ablative therapy to the usual systemic therapy versus the usual systemic therapy alone in treating patients with advanced colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. The addition of ablative local therapy to the usual approach of systemic therapy could be more effective than usual chemotherapy alone by increasing the life of patients with limited metastatic colorectal cancer.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate and compare overall survival (OS) (measured from time of randomization) in patients with newly diagnosed oligometastatic colorectal cancer (oCRC) treated with total ablative therapy (TAT) in addition to standard of care (SOC) systemic therapy versus SOC systemic therapy.

SECONDARY OBJECTIVES:
I. To evaluate and compare event-free survival (EFS) (measured from time of randomization) between the two treatment arms.
II. To assess the adverse events (AE) profile within each of the two treatment arms.
III. To evaluate the time to local recurrence (TLR) (measured from completion of TAT) in patients with newly diagnosed oCRC treated with TAT + SOC systemic therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans throughout the trial. Additionally, patients may optionally undergo endoscopic exam and blood sample collection throughout the trial.

ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo CT or MRI or PET/CT scans throughout the trial. Additionally, patients may optionally undergo endoscopic exam and blood sample collection throughout the trial.

Patients are followed for 5 years from the date of registration/randomization or until death, whichever occurs first.

Treatment Sites in Georgia

Emory Proton Therapy Center
615 Peachtree Street NE
Atlanta, GA 30308
winshipcancer.emory.edu/proton-therapy-center/

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