Clinical trial for Metastatic Colorectal Adenocarcinoma
Official title Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
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 2: a mid-size study of how well it works
- 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
- Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due...
- PRE-REGISTRATION (STEP 0): Pathologically proven diagnosis of metastatic colorectal adenocarcinoma with metastases (biopsy from primary tumor or...
- 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...
See the full eligibility 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...
- PRE-REGISTRATION (STEP 0): Pathologically 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 (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): Liver-only metastatic disease on baseline imaging prior to starting chemotherapy is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in...
- PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
- REGISTRATION (STEP 1): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York...
- REGISTRATION (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational...
- REGISTRATION (STEP 1): A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12...
- 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): Primary tumor is already resected OR patient has had a clinical complete response without surgical resection and no local regrowth (primary rectal tumors only) OR primary tumor is amenable to...
- REGISTRATION (STEP 1): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of radiographic imaging obtained following at least 12 weeks of systemic therapy. Of note, the primary...
- Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.
- Metastatic lesions must be amenable to surgical resection, microwave ablation, radiationSABR or any combination of these modalities.
- Subcentimeter indeterminate lesions such as lung nodules \ 2 months of documented stability prior to the initiation of systemic
- 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.
- 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 12 weeks and a maximum of 52 weeks
- REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 6 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) \>= 1,000/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 \ If Gilbert's disease, use direct bilirubin instead of total bilirubin; direct bilirubin =\< 1.5 ULN if patient to receive FOLFIRI (leucovorin calcium...
- 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
+ 130 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 144 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.