Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability

NCT ID: NCT04804644

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2030-07-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine hydrochloride (memantine) for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test - Revised (HVLT-R), Controlled Oral Word Association (COWA) test, and the Trail Making Test (TMT).

SECONDARY OBJECTIVES:

I. Determine whether SRS relative to HA-WBRT plus memantine for brain metastases from SCLC preserves cognitive function as separately measured by the HVLT-R, COWA, TMT Parts A and B, and Clinical Trial Battery Composite (CTB COMP).

II. Assess perceived difficulties in cognitive abilities using Patient Reported Outcomes Measurement Information System (PROMIS) after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

III. Assess symptom burden using the MD Anderson Symptom Inventory for brain tumor (MDASI-BT) after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

IV. Compare cumulative incidence of intracranial disease progression after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

V. Compare overall survival after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

VI. Compare cumulative incidence of neurologic death after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

VII. Compare the number of salvage procedures used to manage recurrent intracranial disease following SRS relative to HA-WBRT plus memantine for SCLC brain metastases.

VIII. Compare adverse events between the treatment arms according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria.

IX. Compare the risk of developing cerebral necrosis between SRS and HA-WBRT plus memantine in patients receiving concurrent immunotherapy.

EXPLORATORY OBJECTIVES:

I. Compare cumulative incidence of local brain recurrence, distant brain relapse, and leptomeningeal dissemination after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

II. Compare the cost of brain-related therapies and quality-adjusted life years in patients who receive SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

III. Evaluate the time delay to salvage WBRT or HA-WBRT in patients enrolled on the SRS arm.

IV. Evaluate whether a time delay for chemotherapy has an effect on overall survival in patients receiving HA WBRT plus memantine relative to SRS for brain metastases from SCLC.

V. Evaluate baseline magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

VI. Evaluate the correlation between neurocognitive functioning and patient-reported outcomes.

VII. Collect serum, plasma and imaging studies for future translational research analyses.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo SRS over 1 day (in some cases several days).

ARM II: Patients undergo HA-WBRT once daily (QD) for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive memantine orally (PO) QD or twice daily (BID) for up to 24 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection and magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up every 2-3 months for 1 year, and then every 6 months thereafter.

Conditions

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Metastatic Lung Small Cell Carcinoma Metastatic Malignant Neoplasm in the Brain Recurrent Lung Small Cell Carcinoma Stage IV Lung Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (SRS)

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

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Neurocognitive Assessment

Intervention Type OTHER

Ancillary studies

Stereotactic Radiosurgery

Intervention Type RADIATION

Undergo SRS

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Memantine Hydrochloride

Intervention Type DRUG

Given PO

Neurocognitive Assessment

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Whole-Brain Radiotherapy

Intervention Type RADIATION

Undergo HA-WBRT

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Memantine Hydrochloride

Given PO

Intervention Type DRUG

Neurocognitive Assessment

Ancillary studies

Intervention Type OTHER

Stereotactic Radiosurgery

Undergo SRS

Intervention Type RADIATION

Survey Administration

Ancillary studies

Intervention Type OTHER

Whole-Brain Radiotherapy

Undergo HA-WBRT

Intervention Type RADIATION

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Ebixia Namenda SRS Stereotactic External Beam Irradiation stereotactic external-beam radiation therapy Stereotactic Radiation Therapy Stereotactic Radiotherapy stereotaxic radiation therapy stereotaxic radiosurgery WBRT whole-brain radiation therapy

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NRG Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vinai Gondi

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status RECRUITING

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente-Ontario

Ontario, California, United States

Site Status RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status ACTIVE_NOT_RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status ACTIVE_NOT_RECRUITING

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Site Status TERMINATED

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Site Status TERMINATED

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status TERMINATED

Yale University

New Haven, Connecticut, United States

Site Status TERMINATED

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Site Status TERMINATED

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Site Status TERMINATED

Beebe Medical Center

Lewes, Delaware, United States

Site Status RECRUITING

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status SUSPENDED

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Northside Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Northside Hospital-Cherokee

Canton, Georgia, United States

Site Status RECRUITING

Northside Hospital-Forsyth

Cumming, Georgia, United States

Site Status RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status SUSPENDED

Rush-Copley Medical Center

Aurora, Illinois, United States

Site Status RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status RECRUITING

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Site Status RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status RECRUITING

IU Health West Hospital

Avon, Indiana, United States

Site Status RECRUITING

IU Health North Hospital

Carmel, Indiana, United States

Site Status RECRUITING

Goshen Center for Cancer Care

Goshen, Indiana, United States

Site Status RECRUITING

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status RECRUITING

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status ACTIVE_NOT_RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

MedStar Franklin Square Medical Center/Weinberg Cancer Institute

Baltimore, Maryland, United States

Site Status SUSPENDED

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Site Status RECRUITING

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

Site Status RECRUITING

University of Maryland Shore Medical Center at Easton

Easton, Maryland, United States

Site Status RECRUITING

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Site Status RECRUITING

TidalHealth Richard A Henson Cancer Institute

Ocean Pines, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

TidalHealth Peninsula Regional

Salisbury, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Site Status RECRUITING

Caro Cancer Center

Caro, Michigan, United States

Site Status SUSPENDED

Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status SUSPENDED

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Site Status RECRUITING

McLaren-Port Huron

Port Huron, Michigan, United States

Site Status RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status RECRUITING

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status SUSPENDED

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Site Status RECRUITING

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status SUSPENDED

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status RECRUITING

Unity Hospital

Fridley, Minnesota, United States

Site Status ACTIVE_NOT_RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status RECRUITING

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status RECRUITING

Freeman Health System

Joplin, Missouri, United States

Site Status RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status RECRUITING

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status SUSPENDED

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status SUSPENDED

Logan Health Medical Center

Kalispell, Montana, United States

Site Status SUSPENDED

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status RECRUITING

Sands Cancer Center

Canandaigua, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Northern Westchester Hospital

Mount Kisco, New York, United States

Site Status ACTIVE_NOT_RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Upstate Cancer Center Radiation Oncology at Oswego

Oswego, New York, United States

Site Status RECRUITING

Wilmot Cancer Institute Radiation Oncology at Greece

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

University of Rochester

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

Upstate Cancer Center at Hill Radiation Oncology

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Upstate Cancer Center at Verona

Verona, New York, United States

Site Status SUSPENDED

Wilmot Cancer Institute at Webster

Webster, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Case Western Reserve University

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Grant Medical Center

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status RECRUITING

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Site Status RECRUITING

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status SUSPENDED

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status RECRUITING

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, United States

Site Status RECRUITING

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status RECRUITING

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Site Status RECRUITING

Saint Vincent Hospital

Erie, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

Sechler Family Cancer Center

Lebanon, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status SUSPENDED

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status SUSPENDED

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Luke's Hospital-Quakertown Campus

Quakertown, Pennsylvania, United States

Site Status SUSPENDED

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status RECRUITING

Divine Providence Hospital

Williamsport, Pennsylvania, United States

Site Status RECRUITING

WellSpan Health-York Cancer Center

York, Pennsylvania, United States

Site Status RECRUITING

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status RECRUITING

UPMC Memorial

York, Pennsylvania, United States

Site Status RECRUITING

McLeod Regional Medical Center

Florence, South Carolina, United States

Site Status RECRUITING

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Self Regional Healthcare

Greenwood, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

SMC Center for Hematology Oncology Union

Union, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status ACTIVE_NOT_RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

MD Anderson in The Woodlands

Conroe, Texas, United States

Site Status RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

MD Anderson West Houston

Houston, Texas, United States

Site Status RECRUITING

MD Anderson League City

League City, Texas, United States

Site Status RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Site Status RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status RECRUITING

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status SUSPENDED

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

Québec, Quebec, Canada

Site Status RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status SUSPENDED

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status SUSPENDED

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2020-11651

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-CC009

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-CC009

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-CC009

Identifier Type: OTHER

Identifier Source: secondary_id

UG1CA189867

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-CC009

Identifier Type: -

Identifier Source: org_study_id