Could a ZAP of radiation before standard care beat back metastatic kidney cancer?

NCT ID NCT05863351

Disease control Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This Phase III trial tests whether giving a highly targeted form of radiation (SAbR) before standard therapy (immunotherapy or targeted pills) helps people with kidney cancer that has spread to 2-5 spots in the body live longer. About 472 participants are randomly assigned to receive either SAbR followed by standard therapy or standard therapy alone. The study aims to see if the combination is better than standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Stereotactic ablative radiotherapy (SAbR)
What this could lead to: If successful, this approach could extend survival for people with kidney cancer that has spread to a few spots in the body.
What could go wrong: This is a large Phase III trial, but results are not yet available. The added radiation may not improve outcomes and could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 472 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient must be \>= 18 years of age * Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization * Patient may have any RCC histology except a histology that has a sarcomatoid component * Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization * Patient must have favorable or intermediate International Metastatic RCC Database Consortium (IMDC) risk (0-2) at the time of randomization * Patient must have a total of between 2 and 5 metastatic lesions, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria with imaging obtained within 45 days prior to randomization * Patient must have a documentation from a radiation oncologist confirming that all sites are amenable to SAbR * Patient may have received prior therapy in the adjuvant setting as long as potential trial participants have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment * 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 * 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 * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point * Has not undergone a hysterectomy or bilateral oophorectomy * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Patient must have a Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Patients must have adequate organ and bone marrow function as per the recommended guidelines and the respective Food and Drug Administration \[FDA\] package insert required for the systemic therapy chosen by the treating oncologist. We recognize that patients may have varying levels of renal and liver function that will impact which systemic therapy is appropriate for the patient. We do not require all patients to have specific baseline laboratory thresholds but do ask the treating oncologist to attest that the patient has adequate organ and bone marrow function to safely receive one of the first line systemic therapies listed in the protocol as a standard of care treatment option * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study * For patients with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If no previous history, testing for HBV is not required for entry onto the study * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. If no previous history, testing for HCV is not required for entry onto the study * In order to participate in the QOL portion of the protocol, the patient must speak one of the languages in which the NFKSI-19 and EQ-5D-5L is available * NOTE: Sites cannot translate the associated QOL forms Exclusion Criteria: * Patient must not have brain metastases * Patient must not have metastasis involving the following locations: ultra-central (within 2cm of carina) lung, invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum), skin, and scalp * Patient must not have received any prior systemic therapy (except for adjuvant setting) for metastatic RCC * Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease * History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies * Active tuberculosis (purified protein derivative \[PPD\] response without active TB is allowed) * Uncontrolled hypertension (systolic blood pressure \[BP\] \> 190mmHg or diastolic BP \> 110mmHg) * Major surgery within 30 days prior to randomization * Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 30 days prior to randomization * Any arterial thrombotic (ST elevation myocardial infarction \[STEMI\], non-STEMI \[NSTEMI\], cerebrovascular accident \[CVA\], etc.) events within 180 days prior to randomization * Moderate or severe hepatic impairment (child-Pugh B or C) * Untreated pulmonary embolism (PE) or deep-vein thrombosis (DVT) is not allowed. Treated PE or DVT is allowed \> 30 days from diagnosis and when not resulting in respiratory impairment * Unstable cardiac arrhythmia within 180 days prior to randomization * History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to randomization * History of or active inflammatory bowel disease * Malabsorption syndrome within 30 days prior to randomization * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment

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Conditions

The condition(s) this trial relates to.

renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic renal cell carcinoma Stage IV renal cell cancer ajcc V8

Contacts and locations

Locations

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Centralia Oncology Clinic

Centralia, Illinois, 62801, United States
Chelsea Hospital

Chelsea, Michigan, 48118, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States
HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States
Highland Hospital

Rochester, New York, 14620, United States
Illinois CancerCare - Washington

Washington, Illinois, 61571, United States
Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton

Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States
Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States
Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru

Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Lenox Hill Hospital

New York, New York, 10021, United States
Manhattan Eye Ear and Throat Hospital

New York, New York, 10065, United States
Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Mary Greeley Medical Center

Ames, Iowa, 50010, United States
Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States
Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
McFarland Clinic - Ames

Ames, Iowa, 50010, United States
Medical Center of the Rockies

Loveland, Colorado, 80538, United States
Memorial Medical Center

Springfield, Illinois, 62781, United States
Mercy Hospital

Cedar Rapids, Iowa, 52403, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital South

St Louis, Missouri, 63128, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023, United States
Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309, United States
Mission Cancer and Blood - Laurel

Des Moines, Iowa, 50314, United States
Mission Cancer and Blood - West Des Moines

Clive, Iowa, 50325, United States
Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern University

Chicago, Illinois, 60611, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States
OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States
Olathe Health Cancer Center

Olathe, Kansas, 66061, United States
Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States
Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Salina Regional Health Center

Salina, Kansas, 67401, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States
Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States
Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States
UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States
UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116, United States
University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States
University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States
University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States
University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States
University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

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