CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 364 target
Drug / intervention
Chemotherapy +6 moredrug
Likely dose
Not stated in record
Key inclusion· 11
  • Histologically-confirmed metastatic colorectal adenocarcinoma
  • Primary tumor already resected or surgically amenable to resection
  • Four or fewer apparent sites of metastatic disease based on local radiographic imaging
  • Metastatic lesions amenable to surgical resection, microwave ablation, and/or SABR with SABR required for at least one lesion
Key exclusion· 7
  • Known microsatellite instable (MSI) tumor
  • Known BRAF V600E mutation
  • Known peritoneal and/or omental metastases
  • Liver-only metastatic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05673148
NCT05673148Phase 3RecruitingOn Track

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)

Alliance for Clinical Trials in Oncology·interventional·Posted Jan 6, 2023·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating Stereotactic Ablative Radiotherapy, Resection, and 5 other interventions for Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v8. Currently recruiting, targeting 364 participants across 185 sites in 2 countries.

Detailed Summary

This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with 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 (IV) (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. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. 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. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3Recruiting
2023202420252026202720282029203020312032
First PostedJan 6, 2023
Enrollment StartOct 9, 2023
Primary CompletionJul 3, 2028
Study CompletionAug 12, 2032
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 3.5 years agoPrimary completion in 2.0 years

Arms & Interventions

Arm 1 (TAT, SOC chemotherapyexperimental

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 CT or MRI or PET/CT scans throughout the trial.

Procedure: Stereotactic Ablative RadiotherapyProcedure: ResectionProcedure: Microwave AblationDrug: ChemotherapyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
Arm 2 (SOC chemotherapy)active_comparator

Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.

Drug: ChemotherapyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Stereotactic Ablative Radiotherapyprocedure

Undergo SABR

Resectionprocedure

undergo surgical resection

Microwave Ablationprocedure

undergo microwave ablation

Chemotherapydrug

Receive SOC chemotherapy

Computed Tomographyprocedure

Undergo CT scan

Magnetic Resonance Imagingprocedure

Undergo MRI

Positron Emission Tomographyprocedure

Undergo PET scan