Recruiting
Phase 3

High Dose Radiation vs. Whole Brain Radiation

Sponsor:

NRG Oncology

Code:

NCT04804644

Conditions

Metastatic Lung Small Cell Carcinoma

Metastatic Malignant Neoplasm in the Brain

Recurrent Lung Small Cell Carcinoma

Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Magnetic Resonance Imaging

Memantine Hydrochloride

Neurocognitive Assessment

Stereotactic Radiosurgery

Study Details

Brief summary:

This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.

Conditions

Metastatic Lung Small Cell Carcinoma

Metastatic Malignant Neoplasm in the Brain

Recurrent Lung Small Cell Carcinoma

Stage IV Lung Cancer AJCC v8

Study ID

NCT04804644

Start date

Jun 8, 2021

Status verified date

Aug, 2026

Completion date

Jul 1, 2031

Anticipated

Primary completion date

Jun 24, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);

  • Patients with de novo or recurrent small cell lung cancer are permitted.
  • Brain metastases =< 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =< 21 days prior to study entry.

  • The total tumor volume must be 30 cm\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz/2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume.
  • Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.
  • Brain metastases must be diagnosed on MRI, which will include the following elements:

  • REQUIRED MRI ELEMENTS

  • Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.
  • Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).
  • A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.
  • ADDITIONAL RECOMMENDATIONS

  • Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence.
  • Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1.
  • Recommendation is that imaging be performed on a 3 Tesla (3T) MRI.
  • Recommendation is that the study participants be scanned on the same MRI instrument at each time point.
  • Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020.
  • If additional sequences are obtained, total imaging time should not exceed 60 minutes.
  • If additional metastases not known at the time of registration/randomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm\^3, the patient is still considered eligible.
  • History/physical examination
  • Age >= 18
  • Karnofsky performance status of >= 70
  • Creatinine clearance >= 30 ml/min
  • Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-/post-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility.

  • Patients with symptomatic brain metastases and/or brain metastases in eloquent locations (e.g., brainstem, pre-/post central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients.
  • Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted.
  • Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study.
  • Patients may have had prior intracranial surgical resection.
  • Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.
  • The patient must provide study-specific informed consent prior to study entry.

  • Patients with impaired decision-making capacity are not permitted on study.
  • ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION
  • The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.

  • NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
  • PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.

NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.

Exclusion Criteria:

  • Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted.

  • For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments.
  • Brainstem metastasis > 10 cm\^3
  • Prior allergic reaction to memantine.
  • Patients with definitive leptomeningeal metastases.
  • Known history of demyelinating disease such as multiple sclerosis.
  • Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI).
  • Current use of (other N-methyl-D-aspartate \[NMDA\] antagonists) amantadine, ketamine, or dextromethorphan.
  • Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt.

  • Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted.
  • Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (SRS)

Patients undergo SRS over 1 day (in some cases several days). Patients undergo blood sample collection and MRI throughout the study.

active comparator: Arm II (HA-WBRT, memantine)

Patients also undergo HA-WBRT QD for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients will also receive memantine PO QD or BID for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and MRI throughout the study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Magnetic Resonance Imaging

Undergo MRI

Memantine Hydrochloride

Given PO

Neurocognitive Assessment

Ancillary studies

Stereotactic Radiosurgery

Undergo SRS

Survey Administration

Ancillary studies

Whole-Brain Radiotherapy

Undergo HA-WBRT

Primary outcome measure

  • Time to neurocognitive failure [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Locations

Kaiser Permanente-Anaheim

Recruiting

Anaheim, California, United States, 92806

Contacts

Principal Investigator:

Aakash Batra

Kaiser Permanente-Bellflower

Recruiting

Bellflower, California, United States, 90706

Contacts

Principal Investigator:

Aakash Batra

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Contacts

Principal Investigator:

Aakash Batra

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Jason C. Ye

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Jason C. Ye

Kaiser Permanente-Ontario

Recruiting

Ontario, California, United States, 91761

Contacts

Principal Investigator:

Aakash Batra

Moffitt Cancer Center-International Plaza

Recruiting

Tampa, Florida, United States, 33607

Contacts

Principal Investigator:

Hsiang-Hsuan M. Yu

Moffitt Cancer Center - McKinley Campus

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Hsiang-Hsuan M. Yu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Hsiang-Hsuan M. Yu

Moffitt Cancer Center at Wesley Chapel

Recruiting

Wesley Chapel, Florida, United States, 33544

Contacts

Principal Investigator:

Hsiang-Hsuan M. Yu

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Principal Investigator:

Gena H. Volas-Redd

Northside Hospital-Cherokee

Recruiting

Canton, Georgia, United States, 30115

Contacts

Principal Investigator:

Gena H. Volas-Redd

Northside Hospital-Forsyth

Recruiting

Cumming, Georgia, United States, 30041

Contacts

Principal Investigator:

Gena H. Volas-Redd

Rush-Copley Medical Center

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Principal Investigator:

Kalika P. Sarma

Centralia Oncology Clinic

Recruiting

Centralia, Illinois, United States, 62801

Contacts

Principal Investigator:

Bryan A. Faller

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Kalika P. Sarma

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Vinai Gondi

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Kalika P. Sarma

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Vinai Gondi

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Kalika P. Sarma

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Kalika P. Sarma

The Carle Foundation Hospital

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Kalika P. Sarma

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Vinai Gondi

IU Health West Hospital

Recruiting

Avon, Indiana, United States, 46123

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Kevin Shiue

IU Health North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Kevin Shiue

Goshen Center for Cancer Care

Recruiting

Goshen, Indiana, United States, 46526

Contacts

Principal Investigator:

Irina Sparks

Indiana University/Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Kevin Shiue

IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Kevin Shiue

Mary Greeley Medical Center

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Principal Investigator:

Joseph J. Merchant

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Neal E. Dunlap

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Principal Investigator:

Neal E. Dunlap

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Principal Investigator:

Victor T. Lin

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Mark V. Mishra

UM Upper Chesapeake Medical Center

Recruiting

Bel Air, Maryland, United States, 21014

Contacts

Site Public Contact

443-643-3010

Principal Investigator:

Kamila Nowak Choi

Central Maryland Radiation Oncology in Howard County

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Site Public Contact

443-546-1300

Principal Investigator:

Mark V. Mishra

University of Maryland Shore Medical Center at Easton

Recruiting

Easton, Maryland, United States, 21601

Contacts

Principal Investigator:

Mark V. Mishra

UM Baltimore Washington Medical Center/Tate Cancer Center

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Site Public Contact

410-553-8100

Principal Investigator:

Mark V. Mishra

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Samir Narayan

McLaren Cancer Institute-Bay City

Recruiting

Bay City, Michigan, United States, 48706

Contacts

Principal Investigator:

Michael M. Dominello

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Samir Narayan

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Samir Narayan

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Samir Narayan

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Samir Narayan

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Samir Narayan

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Samir Narayan

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Michael M. Dominello

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Principal Investigator:

Michael M. Dominello

McLaren Cancer Institute-Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

Principal Investigator:

Michael M. Dominello

Karmanos Cancer Institute at McLaren Greater Lansing

Recruiting

Lansing, Michigan, United States, 48910

Contacts

Principal Investigator:

Michael M. Dominello

McLaren Cancer Institute-Lapeer Region

Recruiting

Lapeer, Michigan, United States, 48446

Contacts

Principal Investigator:

Michael M. Dominello

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Samir Narayan

McLaren Cancer Institute-Macomb

Recruiting

Mount Clemens, Michigan, United States, 48043

Contacts

Principal Investigator:

Michael M. Dominello

McLaren Cancer Institute-Central Michigan

Recruiting

Mount Pleasant, Michigan, United States, 48858

Contacts

Principal Investigator:

Michael M. Dominello

McLaren Cancer Institute-Northern Michigan

Recruiting

Petoskey, Michigan, United States, 49770

Contacts

Principal Investigator:

Michael M. Dominello

McLaren-Port Huron

Recruiting

Port Huron, Michigan, United States, 48060

Contacts

Principal Investigator:

Michael M. Dominello

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Samir Narayan

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Principal Investigator:

Daniel Almquist

Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, United States, 55337

Contacts

Principal Investigator:

Yan Ji

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

Yan Ji

Minnesota Oncology - Coon Rapids

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

Yan Ji

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

Yan Ji

Minnesota Oncology - Edina

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

Yan Ji

Fairview Clinics and Surgery Center Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Principal Investigator:

Yan Ji

Minnesota Oncology - Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Principal Investigator:

Yan Ji

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

Yan Ji

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

Yan Ji

Monticello Cancer Center

Recruiting

Monticello, Minnesota, United States, 55362

Contacts

Principal Investigator:

Yan Ji

Coborn Cancer Center at Saint Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

Contacts

Principal Investigator:

Donald J. Jurgens

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

Yan Ji

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

Yan Ji

Lakeview Hospital

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Principal Investigator:

Yan Ji

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Principal Investigator:

Yan Ji

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Parkland Health Center - Farmington

Recruiting

Farmington, Missouri, United States, 63640

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Freeman Health System

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Principal Investigator:

Jay W. Carlson

Sainte Genevieve County Memorial Hospital

Recruiting

Sainte Genevieve, Missouri, United States, 63670

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Missouri Baptist Sullivan Hospital

Recruiting

Sullivan, Missouri, United States, 63080

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

BJC Outpatient Center at Sunset Hills

Recruiting

Sunset Hills, Missouri, United States, 63127

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Cooper Hospital University Medical Center

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Site Public Contact

856-325-6757

Principal Investigator:

Justin Mann

Upstate Cancer Center Radiation Oncology at Oswego

Recruiting

Oswego, New York, United States, 13126

Contacts

Principal Investigator:

Michael D. Mix

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Michael D. Mix

Upstate Cancer Center at Hill Radiation Oncology

Recruiting

Syracuse, New York, United States, 13210

Contacts

Principal Investigator:

Michael D. Mix

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Christina K. Cramer

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Principal Investigator:

Daniel Almquist

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

UH Seidman Cancer Center at UH Avon Health Center

Recruiting

Avon, Ohio, United States, 44011

Contacts

Site Public Contact

800-641-2422

Principal Investigator:

Haley K. Perlow

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Kyle Wang

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Haley K. Perlow

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Simeng Zhu

UH Seidman Cancer Center at Lake Health Mentor Campus

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Principal Investigator:

Haley K. Perlow

Mercy Health - Perrysburg Hospital

Recruiting

Perrysburg, Ohio, United States, 43551

Contacts

Principal Investigator:

Aruna C. Gowda

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Principal Investigator:

Kyle Wang

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Tyler Gunter

UPMC Altoona

Recruiting

Altoona, Pennsylvania, United States, 16601

Contacts

Principal Investigator:

Serah Choi

UPMC-Heritage Valley Health System Beaver

Recruiting

Beaver, Pennsylvania, United States, 15009

Contacts

Principal Investigator:

Serah Choi

Carlisle Regional Cancer Center

Recruiting

Carlisle, Pennsylvania, United States, 17015

Contacts

Principal Investigator:

Serah Choi

Chambersburg Hospital

Recruiting

Chambersburg, Pennsylvania, United States, 17201

Contacts

Principal Investigator:

Amit B. Shah

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Principal Investigator:

Fiori Alite

Ephrata Cancer Center

Recruiting

Ephrata, Pennsylvania, United States, 17522

Contacts

Site Public Contact

717-721-4840

Principal Investigator:

Amit B. Shah

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Principal Investigator:

Serah Choi

UPMC Cancer Center at UPMC Horizon

Recruiting

Farrell, Pennsylvania, United States, 16121

Contacts

Principal Investigator:

Serah Choi

Adams Cancer Center

Recruiting

Gettysburg, Pennsylvania, United States, 17325

Contacts

Site Public Contact

877-441-7957

Principal Investigator:

Amit B. Shah

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Serah Choi

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Recruiting

Harrisburg, Pennsylvania, United States, 17109

Contacts

Principal Investigator:

Serah Choi

Sechler Family Cancer Center

Recruiting

Lebanon, Pennsylvania, United States, 17042

Contacts

Principal Investigator:

Amit B. Shah

Geisinger Medical Oncology-Lewisburg

Recruiting

Lewisburg, Pennsylvania, United States, 17837

Contacts

Principal Investigator:

Fiori Alite

UPMC Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Principal Investigator:

Serah Choi

UPMC-Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Site Public Contact

412-647-2811

Principal Investigator:

Serah Choi

UPMC-Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Site Public Contact

412-647-2811

Principal Investigator:

Serah Choi

UPMC-Saint Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

Contacts

Site Public Contact

412-784-4900

Principal Investigator:

Serah Choi

UPMC-Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-621-2334

Principal Investigator:

Serah Choi

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Serah Choi

UPMC-Saint Clair Hospital Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Contacts

Site Public Contact

412-502-3920

Principal Investigator:

Serah Choi

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Principal Investigator:

Fiori Alite

Divine Providence Hospital

Recruiting

Williamsport, Pennsylvania, United States, 17754

Contacts

Principal Investigator:

Serah Choi

WellSpan Health-York Cancer Center

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Site Public Contact

877-441-7957

Principal Investigator:

Amit B. Shah

WellSpan Health-York Hospital

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Site Public Contact

877-441-7957

Principal Investigator:

Amit B. Shah

UPMC Memorial

Recruiting

York, Pennsylvania, United States, 17408

Contacts

Site Public Contact

717-724-6760

Principal Investigator:

Serah Choi

McLeod Regional Medical Center

Recruiting

Florence, South Carolina, United States, 29506

Contacts

Principal Investigator:

Rajesh Bajaj

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Daniel Almquist

MD Anderson in The Woodlands

Recruiting

Conroe, Texas, United States, 77384

Contacts

Principal Investigator:

Martin C. Tom

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Martin C. Tom

MD Anderson West Houston

Recruiting

Houston, Texas, United States, 77079

Contacts

Principal Investigator:

Martin C. Tom

UT MD Anderson - League City

Recruiting

League City, Texas, United States, 77573

Contacts

Principal Investigator:

Martin C. Tom

MD Anderson in Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Principal Investigator:

Martin C. Tom

Langlade Hospital and Cancer Center

Recruiting

Antigo, Wisconsin, United States, 54409

Contacts

Principal Investigator:

Andrew J. Huang

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Principal Investigator:

Joseph A. Bovi

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Principal Investigator:

Andrew M. Baschnagel

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Andrew M. Baschnagel

Froedtert Menomonee Falls Hospital

Recruiting

Menomonee Falls, Wisconsin, United States, 53051

Contacts

Site Public Contact

262-257-5100

Principal Investigator:

Michael W. Straza

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Michael W. Straza

Cancer Center of Western Wisconsin

Recruiting

New Richmond, Wisconsin, United States, 54017

Contacts

Principal Investigator:

Yan Ji

Drexel Town Square Health Center

Recruiting

Oak Creek, Wisconsin, United States, 53154

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Michael W. Straza

Aspirus Cancer Care - James Beck Cancer Center

Recruiting

Rhinelander, Wisconsin, United States, 54501

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Cancer Care - Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54481

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Regional Cancer Center

Recruiting

Wausau, Wisconsin, United States, 54401

Contacts

Site Public Contact

877-405-6866

Principal Investigator:

Andrew J. Huang

Froedtert West Bend Hospital/Kraemer Cancer Center

Recruiting

West Bend, Wisconsin, United States, 53095

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Michael W. Straza

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Principal Investigator:

Isabelle Thibault

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Site Public Contact

306-766-2213

Principal Investigator:

Taskia Mir

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Site Public Contact

306-655-2914

Principal Investigator:

Vijayananda Kundapur

More Information

Sponsor

NRG Oncology

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NRG Oncology on 2026-08-17.