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Metastatic Colorectal AdenocarcinomaCancerProcedureDrugPhase 2

What this study is

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 any combination of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR), surgical resection, 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.

What's being tested

  • Stereotactic Ablative Radiotherapy

    Intervention · PROCEDURE

    Undergo SABR

  • Resection

    Intervention · PROCEDURE

    undergo surgical resection

  • Microwave Ablation

    Intervention · PROCEDURE

    undergo microwave ablation

  • Chemotherapy

    Intervention · DRUG

    Receive SOC chemotherapy

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT scan

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET scan

Study details

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)
Sponsor
Alliance for Clinical Trials in Oncology
Conditions
Metastatic Colorectal Adenocarcinoma · Stage IV Colorectal Cancer AJCC v8 · Oligometastatic Colorectal Carcinoma
Enrolling
146 people
Starts
2023-10-09
Est. completion
2032-08-12
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗