NCT02635009

Brief Summary

This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_2

Geographic Reach
2 countries

281 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

December 22, 2015

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 27, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

7.4 years

First QC Date

December 16, 2015

Results QC Date

May 13, 2024

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III)

    The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points.

    Baseline and six months

  • Number of Participants With Intracranial Relapse at 12 Months (Phase II)

    Intracranial relapse, defined as the development of a new brain metastasis as documented on brain MRI with contrast or head CT with contrast.

    From baseline to 12 months

Secondary Outcomes (35)

  • Percentage of Participants With Neurocognitive Failure (Phase III)

    Randomization to date of failure, death, or last known follow-up whichever occurred first. Maximum follow-up at time of analysis was 7.2 years.

  • Number of Participants With Deterioration in HVLT-R Total Recall Score (Phase III)

    Baseline, 3, 6, 12 months.

  • Number of Participants With Deterioration in HVLT-R Total Recall Score (Phase III)

    Baseline,18, 24 months.

  • Number of Participants With Deterioration in HVLT-R Delayed Recall Score (Phase III)

    Baseline, 3, 12 months.

  • Number of Participants With Deterioration in HVLT-R Delayed Recall Score (Phase III)

    Baseline, 18, 24 months.

  • +30 more secondary outcomes

Other Outcomes (3)

  • Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Sex

    Baseline and six months

  • Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Ethnicity

    Baseline and six months

  • Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Race

    Baseline and six months

Study Arms (2)

PCI using 3DCRT

ACTIVE COMPARATOR

Prophylactic cranial irradiation (PCI) using three-dimensional conformal radiation therapy (3DCRT) for 2 weeks, 5 fractions/week.

Radiation: Three-Dimensional Conformal Radiation Therapy

PCI with HA using IMRT

EXPERIMENTAL

PCI with hippocampal avoidance (HA) using intensity-modulated radiation therapy (IMRT) for 2 weeks, 5 fractions/week.

Radiation: Intensity-Modulated Radiation Therapy

Interventions

daily fractions

Also known as: 3-dimensional conformal radiation therapy, 3-dimensional radiation therapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, 3DCRT
PCI using 3DCRT

daily fractions

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
PCI with HA using IMRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration
  • High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
  • Patients must have received chemotherapy and be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy. Note:
  • Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration.
  • For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted.
  • Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan. To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan must use the smallest possible axial slice thickness not exceeding 1.5 mm.
  • This MRI must be obtained within 56 days prior to Step 1 registration. Note: The MRI study is mandatory irrespective of randomization to the experimental or control arm of this study.
  • Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:
  • History/physical examination;
  • CT of the chest and abdomen with contrast (does not have to be done if the patient has had a positron emission tomography (PET) / CT scan prior to initiating chemotherapy or thoracic radiotherapy);
  • MRI of the brain with contrast or diagnostic head CT with contrast;
  • For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC.
  • After chemotherapy, patients must be restaged prior to Step 1 registration using the same diagnostic work-up as required pre-chemotherapy. Repeat PET/CT or bone scan is not required. Patients must have:
  • History/physical examination within 30 days of Step 1 registration;
  • No CNS metastases (Repeat MRI required) within 56 days prior to Step 1 registration;
  • +10 more criteria

You may not qualify if:

  • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
  • Radiographic evidence of central nervous system (CNS) metastases
  • Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
  • Planned concurrent chemotherapy during PCI
  • Concurrent atezolizumab permitted
  • Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted
  • Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
  • Severe, active comorbidity, 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
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Uncontrolled, clinically significant cardiac arrhythmias
  • HIV positive with CD4 count \< 200 cells/microliter;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (281)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Lewis and Faye Manderson Cancer Center

Tuscaloosa, Alabama, 35401, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Marin General Hospital

Greenbrae, California, 94904, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Mercy Cancer Center

Merced, California, 95340, United States

Location

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

Location

Saint Joseph Hospital - Orange

Orange, California, 92868, United States

Location

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Hartford HealthCare - Saint Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Northside Hospital-Forsyth

Cumming, Georgia, 30041, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

Location

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

Location

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

Location

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

Location

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

Location

Edward Hines Jr VA Hospital

Hines, Illinois, 60141, United States

Location

Condell Memorial Hospital

Libertyville, Illinois, 60048, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

Location

Ascension Saint Vincent Anderson

Anderson, Indiana, 46016, United States

Location

Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States

Location

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

IU Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

Saint Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MedStar Franklin Square Medical Center/Weinberg Cancer Institute

Baltimore, Maryland, 21237, United States

Location

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States

Location

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States

Location

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061, United States

Location

TidalHealth Richard A Henson Cancer Institute

Ocean Pines, Maryland, 21811, United States

Location

TidalHealth Peninsula Regional

Salisbury, Maryland, 21801, United States

Location

UM Saint Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

McLaren Cancer Institute-Bay City

Bay City, Michigan, 48706, United States

Location

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States

Location

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

Location

Chelsea Hospital

Chelsea, Michigan, 48118, United States

Location

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, 48346, United States

Location

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, 48346, United States

Location

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

Location

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, 48334, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

McLaren Cancer Institute-Flint

Flint, Michigan, 48532, United States

Location

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, 48446, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Michigan Healthcare Professionals Macomb

Macomb, Michigan, 48044, United States

Location

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, 48043, United States

Location

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, 48858, United States

Location

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States

Location

McLaren Cancer Institute-Owosso

Owosso, Michigan, 48867, United States

Location

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

McLaren-Port Huron

Port Huron, Michigan, 48060, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085, United States

Location

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States

Location

Michigan Healthcare Professionals Troy

Troy, Michigan, 48098, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic Radiation Therapy-Northfield

Northfield, Minnesota, 55057, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Community Medical Center

Missoula, Montana, 59804, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Wentworth-Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Virtua Memorial

Mount Holly, New Jersey, 08060, United States

Location

Virtua Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Northwell Health Imbert Cancer Center

Bay Shore, New York, 11706, United States

Location

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Arnot Ogden Medical Center/Falck Cancer Center

Elmira, New York, 14905, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

Location

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

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210, United States

Location

Atrium Health University City/LCI-University

Charlotte, North Carolina, 28262, United States

Location

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States

Location

Atrium Health Union/LCI-Union

Monroe, North Carolina, 28112, United States

Location

Atrium Health Cleveland/LCI-Cleveland

Shelby, North Carolina, 28150, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Summa Health System - Akron Campus

Akron, Ohio, 44304, United States

Location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

Geauga Hospital

Chardon, Ohio, 44024, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Mount Carmel Health Center West

Columbus, Ohio, 43222, United States

Location

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415, United States

Location

Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States

Location

Cleveland Clinic Cancer Center Independence

Independence, Ohio, 44131, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, 44130, United States

Location

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

Location

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

Jefferson Abington Hospital

Abington, Pennsylvania, 19001, United States

Location

Crozer-Keystone Regional Cancer Center at Broomall

Broomall, Pennsylvania, 19008, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

Location

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Crozer Regional Cancer Center at Brinton Lake

Glen Mills, Pennsylvania, 19342, United States

Location

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

Location

Riddle Memorial Hospital

Media, Pennsylvania, 19063, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Penn State Health Saint Joseph Medical Center

Reading, Pennsylvania, 19605, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Self Regional Healthcare

Greenwood, South Carolina, 29646, United States

Location

The Radiation Oncology Center-Hilton Head/Bluffton

Hilton Head Island, South Carolina, 29926, United States

Location

Lancaster Radiation Therapy Center

Lancaster, South Carolina, 29720, United States

Location

Rock Hill Radiation Therapy Center

Rock Hill, South Carolina, 29730, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Sanford USD Medical Center - Sioux Falls

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

Location

Covenant Health Cancer Centers

Knoxville, Tennessee, 37916, United States

Location

Blount Memorial Hospital

Maryville, Tennessee, 37804, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States

Location

Ogden Regional Medical Center

Ogden, Utah, 84405, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

Wheeling Hospital/Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

Location

Ascension Southeast Wisconsin Hospital - Elmbrook Campus

Brookfield, Wisconsin, 53045, United States

Location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic Health System Eau Claire Hospital-Luther Campus

Eau Claire, Wisconsin, 54703, United States

Location

Ascension Saint Francis - Reiman Cancer Center

Franklin, Wisconsin, 53132, United States

Location

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, 53038, United States

Location

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

Location

Ascension All Saints Hospital

Racine, Wisconsin, 53405, United States

Location

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

Location

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

Location

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

Location

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

Location

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, L3Y 2P9, Canada

Location

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9, Canada

Location

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

Québec, Quebec, G1R 2J6, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (2)

  • Gondi V, Pugh SL, Mehta MP, Wefel JS, Tome WA, Sun AY, Grecula J, Redmond KJ, Fogh S, Gaspar L, Konski A, Bovi J, Robinson CG, Corn B, Videtic GM, Lok BH, Yoon HA, Heinzerling JH, DeNittis AS, McGarry RC, Devisetty K, Kundapur V, Wu AJ, McCarron EC, Thibault I, Simon EL, Baschnagel AM, Narayan S, Pollock J, Paulus R, Kachnic LA; NRG Oncology. Hippocampal Avoidance During Prophylactic Cranial Irradiation for Patients With Small Cell Lung Cancer: Randomized Phase II/III Trial NRG-CC003. J Clin Oncol. 2025 Nov 10;43(32):3516-3525. doi: 10.1200/JCO-25-00221. Epub 2025 Aug 11.

  • Ishibashi A, Kurosaki H, Miura K, Utsumi N, Sakurai H. Influence of Modulation Factor on Treatment Plan Quality and Irradiation Time in Hippocampus-Sparing Whole-Brain Radiotherapy Using Tomotherapy. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211045497. doi: 10.1177/15330338211045497.

MeSH Terms

Interventions

Radiotherapy, ConformalRadiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Limitations and Caveats

Phase II participants were included in the phase III analysis.

Results Point of Contact

Title
Wendy Seiferheld
Organization
NRG Oncology

Study Officials

  • Vinai Gondi

    NRG Oncology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

December 22, 2015

Primary Completion

May 18, 2023

Study Completion

September 4, 2025

Last Updated

April 24, 2026

Results First Posted

June 27, 2024

Record last verified: 2026-04

Locations