RecruitingPhase 2

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

A Pragmatic Randomized Phase II Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: MRI scans, CT scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans throughout the trial."
  • "Additionally, patients may undergo endoscopic exam and optional blood sample collection throughout the trial."
  • "Patients also undergo CT or MRI or PET/CT scans throughout the trial. ."
  • "After completion of study treatment, patients are followed for 5 years from the date of registration."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with colorectal cancer that has spread to no more than 4 body sites. It tests whether adding treatments aimed at those cancer sites to usual cancer medicines helps people live longer than medicines alone. These added treatments may include surgery, focused radiation, or heat from a needle placed in the tumor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with colorectal adenocarcinoma, a type of colon or rectal cancer, confirmed by a tissue sample.
  • Have cancer that can be measured on scans, with no more than 4 sites of spread after treatment. All sites must be treatable with surgery, focused radiation, or needle-based heat treatment.
  • Have received 12 to 52 weeks of first treatment with medicines for the cancer's spread, with no clear worsening. Any earlier treatment meant to remove or cure the cancer must have ended at least 6 months before the spread was diagnosed.
  • The original tumor must be removed or able to be removed by surgery. A rectal tumor may also qualify if it fully responded to treatment and has not grown back.
  • Have no known MSI tumor or BRAF V600E mutation, which are certain changes in the cancer's genetic material.
  • Cancer must not have spread only to the liver on scans before chemotherapy, or to the belly lining or its fatty covering. Treated brain tumors must show no further growth on follow-up scans.
  • Be able to care for yourself and be out of bed at least half the day. Blood counts, kidney and liver tests, and heart health, when checked, must meet study limits.
  • Not be pregnant or breastfeeding. If you could become pregnant, have a negative pregnancy test within 14 days before joining. People who could have children must agree to use birth control during the study.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) * 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 omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants * 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 addition to the liver on initial imaging to be eligible for this study. Of note, patients who have metastatic disease to the liver and at least one other site on initial imaging who have liver-only metastatic disease on subsequent imaging after completing initial systemic therapy are eligible * 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 Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * 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 efficacy assessment of the investigational regimen are eligible for this trial * 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 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * 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 surgical resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible * 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 tumor and associated regional lymph nodes do not count as one of the sites of disease. * 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 \< 5 mm in size may be considered metastases unless there are \> 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, a negative pregnancy test done =\< 14 days prior to registration is required * 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 =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 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, 5-fluorouracil, and irinotecan); direct bilirubin ≤ 3.0 x ULN if patient to receive mFOLFOX6 (leucovorin calcium, 5-fluorouracil, and oxaliplatin) * 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 metastatic liver disease, =\< 5 x ULN * 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 required for eligibility * REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study Exclusion Criteria: * N/A

    Study sites (188)

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    DE

    FL

    • UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, FL 33146Site Public Contact · Study contact · 305-243-2647Agustin Pimentel · Principal investigatorMore trials in Coral Gables
    • UM Sylvester Comprehensive Cancer Center at Coral Springs · Coral Springs, FL 33065Site Public Contact · Study contact · 305-243-2647Agustin Pimentel · Principal investigatorMore trials in Coral Springs
    • UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL 33442Site Public Contact · Study contact · 305-243-2647Agustin Pimentel · Principal investigatorMore trials in Deerfield Beach
    • UM Sylvester Comprehensive Cancer Center at Doral · Doral, FL 33166Site Public Contact · Study contact · kginnity@med.miami.eduAgustin Pimentel · Principal investigatorMore trials in Doral
    • UF Health Cancer Institute - Gainesville · Gainesville, FL 32610Site Public Contact · Study contact · 352-273-8010Thomas J. George · Principal investigatorMore trials in Gainesville
    • UM Sylvester Comprehensive Cancer Center at Hollywood · Hollywood, FL 33021Site Public Contact · Study contact · 305-243-2647Agustin Pimentel · Principal investigatorMore trials in Hollywood
    • Jupiter Medical Center · Jupiter, FL 33458More trials in Jupiter
    • University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL 33136Site Public Contact · Study contact · 305-243-2647Agustin Pimentel · Principal investigatorMore trials in Miami
    • Miami Cancer Institute · Miami, FL 33176More trials in Miami
    • UM Sylvester Comprehensive Cancer Center at Kendall · Miami, FL 33176Site Public Contact · Study contact · 305-243-2647Agustin Pimentel · Principal investigatorMore trials in Miami
    • UM Sylvester Comprehensive Cancer Center at Plantation · Plantation, FL 33324Site Public Contact · Study contact · 305-243-2647Agustin Pimentel · Principal investigatorMore trials in Plantation

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    • UI Health Care Mission Cancer and Blood - Ankeny Clinic · Ankeny, IA 50023Site Public Contact · Study contact · 515-241-3305Richard L. Deming · Principal investigatorMore trials in Ankeny
    • University of Iowa Healthcare Cancer Services Quad Cities · Bettendorf, IA 52722Site Public Contact · Study contact · 563-355-7733 · katherine-daprile@uiowa.eduIoannis A. Voutsadakis · Principal investigatorMore trials in Bettendorf
    • Mercy Cancer Center-West Lakes · Clive, IA 50325Site Public Contact · Study contact · 515-241-3305Richard L. Deming · Principal investigatorMore trials in Clive
    • UI Health Care Mission Cancer and Blood - West Des Moines Clinic · Clive, IA 50325Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Clive
    • Greater Regional Medical Center · Creston, IA 50801More trials in Creston
    • Iowa Methodist Medical Center · Des Moines, IA 50309Site Public Contact · Study contact · 515-241-6727Seema Harichand-Herdt · Principal investigatorMore trials in Des Moines
    • UI Health Care Mission Cancer and Blood - Des Moines Clinic · Des Moines, IA 50309Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Des Moines
    • Mercy Medical Center - Des Moines · Des Moines, IA 50314Site Public Contact · Study contact · 515-241-3305Richard L. Deming · Principal investigatorMore trials in Des Moines
    • UI Health Care Mission Cancer and Blood - Laurel Clinic · Des Moines, IA 50314Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Des Moines
    • University of Iowa/Holden Comprehensive Cancer Center · Iowa City, IA 52242Site Public Contact · Study contact · 800-237-1225Ioannis A. Voutsadakis · Principal investigatorMore trials in Iowa City
    • UI Health Care Mission Cancer and Blood - Waukee Clinic · Waukee, IA 50263Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Waukee
    • Mercy Medical Center-West Lakes · West Des Moines, IA 50266Site Public Contact · Study contact · 515-241-3305Richard L. Deming · Principal investigatorMore trials in West Des Moines

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