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New treatment option for Metastatic Colorectal Adenocarcinoma
Official title Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
ClinicalTrials.gov ID: NCT05673148
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal adenocarcinoma.
Also referred to as Chemo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma
- PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
- PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
- PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed...
- PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and...
See the full eligibility criteria
- PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma
- PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
- PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
- PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or...
- PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the...
- PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.
- Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.
- Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study.
- Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and/or stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the...
- Single sites include:
- Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field
- PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
- PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration
- REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration
- REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined
- REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1
- REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months)
- REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease
- REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects. \ Therefore, for women of childbearing potential only...
- REGISTRATION (STEP 1): Age \>= 18 years
- REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
- REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- REGISTRATION (STEP 1): Platelet count \>= 50,000/mm\^3
- REGISTRATION (STEP 1): Creatinine =\ = 30 mL/min \ Calculated using the Cockcroft-Gault equation
- REGISTRATION (STEP 1): Total bilirubin =\< 1.5 x ULN
- REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =\< 3.0 x ULN \ In the event of...
- REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not...
- REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study
The study team makes the final eligibility decision.
Where it's taking place
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Lewes, Delaware, United States
- Millville, Delaware, United States
- Newark, Delaware, United States
- Rehoboth Beach, Delaware, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Jupiter, Florida, United States
+ 129 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingman, Arizona, United States; Phoenix, Arizona, United States; Beverly Hills, California, United States; Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States and 143 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.