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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: Recruiting Phase 3 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
o Description: The hazard ratio (HR) for OS will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. The Kaplan-Meier methodology will be used to estimate the median OS for each treatment arm, and Kaplan-Meier curves will be produced. OS will also be compared between treatment arms using the log rank test
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 |
What NCT05673148 shows while recruiting
NCT05673148 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (296% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
Similar trials for Stage IV Colorectal Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05673148's enrollment target sits among peer trials
364 3rd of 22 higher than 20 of 22 other Stage IV Colorectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Colorectal Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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