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

StatusRecruiting
PhasePhase 2
Started2023-10-09
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 60% 364 → 146 participants
See other at-risk trials from Alliance for Clinical Trials in Oncology

Amendment history

2026-09-01
critical
Study Status, Contacts/Locations v25
Phase changed: Phase 3 → Phase 2
Enrollment reduced: 364 → 146 participants
Study sitesdetails revised at 11 of 187 sites
2026-08-31
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Eligibility, Contacts/Locations v24
PhasePhase 3→Phase 2
Enrollment target364→146
Eligibility criteria+2,064 characters
Inclusion Criteria: Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implan [...] PRE-REGISTRATION (STEP 0): Histologically-confirmedPathologically proven diagnosis of metastatic colorectal adenocarcinoma with metastases (biopsy from primary tumor or metastatic site is acceptable) PRE-REGISTRATION (STEP 0): No known microsatellite instable [...] e absence of peritone [...]
Study description+310 characters
[...] 2 arms. ARM 1: Patients undergo TAT on study, consisting of any combination of SABR with or without surgical resection and/or microwave ablation on study. Patients also receive SOC chemotherapy on study. Patients [...] on emission tomography (PET)/CT scans throughout the trial. Additionally, patients may undergo endoscopic exam and optional blood sample collection throughout the trial. ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial. . Additionally, patients may undergo endoscopic exam and optional blood sa [...]
Study sitesdetails revised at 1 of 187 sites
Study title-4 characters
[...] Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur StudyTrial
2026-08-04
minor
Study Status, Contacts/Locations v23
Study sites186→187
2026-07-01
minor
Study Status, Contacts/Locations v22
Study sites185→186
2026-06-01
minor
Study Status, Contacts/Locations v21
Study sites183→185
Show 20 earlier versions
2026-05-07
minor
Study Status, Contacts/Locations v20
Study sites183 entries, revised
Cedars-Sinai Medical Center
2026-04-06
minor
Study Status, Contacts/Locations v19
Study sites182→183
2026-03-02
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 8 of 182 sites
2026-02-03
minor
Study Status, Contacts/Locations v17
Study sites177→182
2025-12-08
minor
Study Status, Contacts/Locations v16
Study sites176→177
2025-11-04
minor
Study Status, Contacts/Locations v15
Study sitesdetails revised at 3 of 176 sites
2025-10-07
minor
Study Status, Contacts/Locations v14
Study sites166→176
2025-08-28
minor
Study Status, Contacts/Locations v13
Study sites148→166
2025-06-24
minor
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v12
Study sites130→148
Study titlerevised
[...] Therapy Treatment for Limited Metastatic Colorectal Cancer, theThe ERASur Study
2025-01-09
minor
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v11
Primary completion date2028-06-03→2028-07-03
Start date2023-01-10→2023-10-09
Study sitesdetails revised at 125 of 130 sites
Study titlerevised
[...] Therapy Treatment for Limited Metastatic Colorectal Cancer, Thethe ERASur Study
2024-12-24
minor
Study Status, Contacts/Locations v10
Study sites125→130
2024-10-24
minor
Study Status, Contacts/Locations v9
Study sites116→125
2024-08-01
minor
Study Status, Contacts/Locations v8
Study sites108→116
2024-05-22
minor
Study Status, Contacts/Locations v7
Study sites108 entries, revised
MedicalMission OncologyCancer and HematologyBlood Associates- West Des Moines MedicalMission OncologyCancer and HematologyBlood Associates- Des Moines Trinity Health Saint Joseph Mercy Hospital Ann Arbor SaintTrinity JosephHealth MercyMedical Center - Brighton SaintTrinity JosephHealth MercyMedical Center - Canton Benefis Healthcare- Sletten Cancer Institute DaytonPremier Blood and Cancer Center Dayton Physician LLC -Miami Valley Hospital NorthEnglewood
2024-04-08
minor
Study Status, Contacts/Locations v6
Study sites97→108
2024-02-19
minor
Study Status, Contacts/Locations v5
Study sites82→97
2023-11-30
minor
Study Status, Contacts/Locations v4
Study sites59→82
2023-07-21
minor
Study Status, Contacts/Locations v3
Study sites11→59
2023-07-05
minor
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2023-04-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→11
2022-12-21
minor
Original filing
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.
Trial Details
NCT Number NCT05673148
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Oligometastatic Colorectal Carcinoma
Enrollment 146 participants
Start Date 2023-10-09
Primary Completion 2028-07-03 (estimated)
Study Completion 2032-08-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-03