RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or Fewer Brain Metastases From Small Cell Lung Cancer

Quick Facts

Study Start:2021-06-10

Study Completion:2030-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04804644

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * Ten or fewer brain metastases ≤ 3 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. * 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. * 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 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. * 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. Patients must have completed prior intracranial surgical resection at least 14 days prior to registration. * 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.	* 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. * Prior allergic reaction to memantine. * Intractable seizures while on adequate anticonvulsant therapy; more than 1 seizure per month for the past 2 months. * 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). * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Inclusion Criteria

Exclusion 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.
* Ten or fewer brain metastases ≤ 3 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.
* 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.
* 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 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.
* 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. Patients must have completed prior intracranial surgical resection at least 14 days prior to registration.
* 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.

* 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.
* Prior allergic reaction to memantine.
* Intractable seizures while on adequate anticonvulsant therapy; more than 1 seizure per month for the past 2 months.
* 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).
* Severe, active co-morbidity defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Transmural myocardial infarction within the last 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Contacts and Locations

Principal Investigator

Vinai Gondi

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054

United States

Kaiser Permanente-Anaheim

Anaheim, California, 92806

United States

Kaiser Permanente-Bellflower

Bellflower, California, 90706

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Kaiser Permanente-Ontario

Ontario, California, 91761

United States

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909

United States

Memorial Hospital North

Colorado Springs, Colorado, 80920

United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830

United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437

United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510

United States

Yale University

New Haven, Connecticut, 06520

United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611

United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385

United States

Beebe Medical Center

Lewes, Delaware, 19958

United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718

United States

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, 33544

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Northside Hospital

Atlanta, Georgia, 30342

United States

Northside Hospital-Cherokee

Canton, Georgia, 30115

United States

Northside Hospital-Forsyth

Cumming, Georgia, 30041

United States

Memorial Health University Medical Center

Savannah, Georgia, 31404

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

OSF Saint Francis Medical Center

Peoria, Illinois, 61637

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

The Carle Foundation Hospital

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Goshen Center for Cancer Care

Goshen, Indiana, 46526

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

Baptist Health Lexington

Lexington, Kentucky, 40503

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

United States

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, 21401

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

MedStar Franklin Square Medical Center/Weinberg Cancer Institute

Baltimore, Maryland, 21237

United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014

United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044

United States

University of Maryland Shore Medical Center at Easton

Easton, Maryland, 21601

United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

United States

TidalHealth Richard A Henson Cancer Institute

Ocean Pines, Maryland, 21811

United States

TidalHealth Peninsula Regional

Salisbury, Maryland, 21801

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Caro Cancer Center

Caro, Michigan, 48723

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, 48453

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Unity Hospital

Fridley, Minnesota, 55432

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Monticello Cancer Center

Monticello, Minnesota, 55362

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Lakeview Hospital

Stillwater, Minnesota, 55082

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

Freeman Health System

Joplin, Missouri, 64804

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Montefiore Medical Center-Einstein Campus

Bronx, New York, 10461

United States

Montefiore Medical Center-Weiler Hospital

Bronx, New York, 10461

United States

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

United States

Sands Cancer Center

Canandaigua, New York, 14424

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042

United States

Northern Westchester Hospital

Mount Kisco, New York, 10549

United States

Wilmot Cancer Institute Radiation Oncology at Greece

Rochester, New York, 14606

United States

University of Rochester

Rochester, New York, 14642

United States

State University of New York Upstate Medical University

Syracuse, New York, 13210

United States

Upstate Cancer Center at Verona

Verona, New York, 13478

United States

Wilmot Cancer Institute at Webster

Webster, New York, 14580

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, 43015

United States

Grady Memorial Hospital

Delaware, Ohio, 43015

United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060

United States

Mercy Health Perrysburg Cancer Center

Perrysburg, Ohio, 43551

United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, 43623

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, 18104

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015

United States

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317

United States

Chambersburg Hospital

Chambersburg, Pennsylvania, 17201

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, 18045

United States

Ephrata Cancer Center

Ephrata, Pennsylvania, 17522

United States

Saint Vincent Hospital

Erie, Pennsylvania, 16544

United States

Adams Cancer Center

Gettysburg, Pennsylvania, 17325

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

Sechler Family Cancer Center

Lebanon, Pennsylvania, 17042

United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837

United States

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243

United States

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, 18951

United States

Saint Luke's Hospital-Quakertown Campus

Quakertown, Pennsylvania, 18951

United States

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania, 18360

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

United States

Divine Providence Hospital

Williamsport, Pennsylvania, 17754

United States

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403

United States

WellSpan Health-York Hospital

York, Pennsylvania, 17403

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

McLeod Regional Medical Center

Florence, South Carolina, 29506

United States

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341

United States

Self Regional Healthcare

Greenwood, South Carolina, 29646

United States

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651

United States

Spartanburg Medical Center

Spartanburg, South Carolina, 29303

United States

MGC Hematology Oncology-Union

Union, South Carolina, 29379

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

MD Anderson in The Woodlands

Conroe, Texas, 77384

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

MD Anderson West Houston

Houston, Texas, 77079

United States

MD Anderson League City

League City, Texas, 77573

United States

MD Anderson in Sugar Land

Sugar Land, Texas, 77478

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501

United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481

United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

United States

Collaborators and Investigators

Sponsor: NRG Oncology

Vinai Gondi, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-10

Study Completion Date2030-07-01

Study Record Updates

Study Start Date2021-06-10

Study Completion Date2030-07-01

Terms related to this study

Additional Relevant MeSH Terms

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