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NCT05673148 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
A Phase 3 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 364
- Enrollment target
- 20
- Study locations
NCT05673148 is a Phase 3 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 364 participants, above the 92-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (296% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT05673148, a Phase 3 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 364 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Chemotherapy
- PROCEDURE Resection
- PROCEDURE Stereotactic Ablative Radiotherapy
- PROCEDURE Microwave Ablation
Study Locations (20)
Delaware
- Beebe Medical Center - Lewes
- Beebe South Coastal Health Campus - Millville
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
- Christiana Care Health System-Christiana Hospital - Newark
- Beebe Health Campus - Rehoboth Beach
- Christiana Care Health System-Wilmington Hospital - Wilmington
California
- Tower Cancer Research Foundation - Beverly Hills
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Cedars Sinai Medical Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
Arizona
- Kingman Regional Medical Center - Kingman
- Mayo Clinic Hospital in Arizona - Phoenix
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
- George Washington University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2023-10-09 |
| Est. Completion | 2032-08-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05673148
The ClinicalTrials.gov registry entry for NCT05673148 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 364 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 92-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (296% higher). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT05673148 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Delaware, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05673148 about?
NCT05673148 is a clinical study titled "Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study". 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 wi...
What is the current status of trial NCT05673148?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 364 participants. The study started on 2023-10-09. Estimated completion is 2032-08-12.
What conditions does trial NCT05673148 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma.
What interventions are being tested in trial NCT05673148?
The interventions under investigation include: Computed Tomography (PROCEDURE), Chemotherapy (DRUG), Resection (PROCEDURE), Stereotactic Ablative Radiotherapy (PROCEDURE), Microwave Ablation (PROCEDURE).
Who is sponsoring clinical trial NCT05673148?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05673148 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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