S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

Study Overview

• Status: Active, not recruiting
• Conditions: Extensive Stage Lung Small Cell Carcinoma; Limited Stage Lung Small Cell Carcinoma; Lung Small Cell Carcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Radiation: Prophylactic Cranial Irradiation

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).

SECONDARY OBJECTIVES:

I. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms.

II. To compare brain-metastasis-free survival between the arms. III. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease.

IV. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.

V. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.

VI. To compare the frequency and severity of toxicities between the two arms.

ADDITIONAL OBJECTIVE:

I. To collect blood for banking.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

ARM II: Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

• Study Type: Interventional
• Enrollment (Estimated): 668
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 6V5
      • BCCA-Vancouver Island Cancer Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Atlantic Health Sciences Corporation-Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Doctor H. Bliss Murphy Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre at Hamilton Health Sciences
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network-Princess Margaret Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre- Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H3H 2R9
      • The Research Institute of the McGill University Health Centre (MUHC)
    • Québec, Quebec, Canada, G1R 2J6
      • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Centre hospitalier regional de Trois-Rivieres
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
• Chile
  • Independence, Chile, 8380455
    • Instituto Nacional del Cancer
• Colombia
  • Bogotá, Colombia, 99999
    • Instituto Nacional de Cancerologia
• Mexico
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • Instituto Nacional De Cancerologia de Mexico
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital and Research Centre
• South Korea
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 410-769
      • National Cancer Center-Korea
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Cancer Center
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Katmai Oncology Group
    • Fairbanks, Alaska, United States, 99701
      • Fairbanks Memorial Hospital
  • Arizona
    • Tucson, Arizona, United States, 85704
      • University of Arizona Cancer Center-Orange Grove Campus
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center-North Campus
  • California
    • Corona, California, United States, 92882
      • City of Hope Corona
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
    • Loma Linda, California, United States, 92357
      • Veterans Affairs Loma Linda Healthcare System
    • Long Beach, California, United States, 90822
      • Tibor Rubin VA Medical Center
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Los Angeles General Medical Center
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • San Francisco, California, United States, 94121
      • Veterans Affairs Medical Center - San Francisco
    • South Pasadena, California, United States, 91030
      • City of Hope South Pasadena
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center
    • Aurora, Colorado, United States, 80045
      • UCHealth University of Colorado Hospital
    • Colorado Springs, Colorado, United States, 80909
      • UCHealth Memorial Hospital Central
    • Colorado Springs, Colorado, United States, 80920
      • Memorial Hospital North
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Fort Collins, Colorado, United States, 80528
      • Cancer Care and Hematology-Fort Collins
    • Greeley, Colorado, United States, 80631
      • UCHealth Greeley Hospital
    • Greeley, Colorado, United States, 80631
      • Banner North Colorado Medical Center
    • Highlands Ranch, Colorado, United States, 80129
      • UCHealth Highlands Ranch Hospital
    • Lakewood, Colorado, United States, 80228
      • Saint Anthony Hospital
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
    • Loveland, Colorado, United States, 80539
      • Banner McKee Medical Center
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Smilow Cancer Hospital Care Center at Greenwich
    • Guilford, Connecticut, United States, 06437
      • Smilow Cancer Hospital Care Center - Guilford
    • Hamden, Connecticut, United States, 06518
      • Smilow Cancer Hospital-Hamden Care Center
    • New Haven, Connecticut, United States, 06520
      • Yale University
    • Trumbull, Connecticut, United States, 06611
      • Smilow Cancer Hospital Care Center-Trumbull
    • Waterford, Connecticut, United States, 06385
      • Smilow Cancer Hospital Care Center - Waterford
    • West Haven, Connecticut, United States, 06516
      • Veterans Affairs Connecticut Healthcare System-West Haven Campus
  • Delaware
    • Millville, Delaware, United States, 19967
      • Beebe South Coastal Health Campus
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants PA
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System-Christiana Hospital
    • Rehoboth Beach, Delaware, United States, 19971
      • Beebe Health Campus
  • Florida
    • Atlantis, Florida, United States, 33462
      • John Fitzgerald Kennedy Medical Center
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Coral Gables, Florida, United States, 33146
      • UM Sylvester Comprehensive Cancer Center at Coral Gables
    • Deerfield Beach, Florida, United States, 33442
      • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    • Gainesville, Florida, United States, 32610
      • University of Florida Health Science Center - Gainesville
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Northside Hospital-Alpharetta
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • Canton, Georgia, United States, 30115
      • Northside Hospital-Cherokee
    • Columbus, Georgia, United States, 31904
      • John B Amos Cancer Center
    • Cumming, Georgia, United States, 30041
      • Northside Hospital-Forsyth
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical Center
    • Newnan, Georgia, United States, 30265
      • CTCA at Southeastern Regional Medical Center
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center
    • Honolulu, Hawaii, United States, 96817
      • The Cancer Center of Hawaii-Liliha
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care Inc - Waterfront Plaza
    • Honolulu, Hawaii, United States, 96813
      • Queen's Cancer Cenrer - POB I
    • Honolulu, Hawaii, United States, 96813
      • Straub Clinic and Hospital
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center
    • Honolulu, Hawaii, United States, 96817
      • Kuakini Medical Center
    • Honolulu, Hawaii, United States, 96817
      • Queen's Cancer Center - Kuakini
    • ‘Aiea, Hawaii, United States, 96701
      • Hawaii Cancer Care - Westridge
    • ‘Aiea, Hawaii, United States, 96701
      • Pali Momi Medical Center
    • ‘Aiea, Hawaii, United States, 96701
      • The Cancer Center of Hawaii-Pali Momi
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Health - Coeur d'Alene
    • Post Falls, Idaho, United States, 83854
      • Kootenai Clinic Cancer Services - Post Falls
  • Illinois
    • Alton, Illinois, United States, 62002
      • Alton Memorial Hospital
    • Alton, Illinois, United States, 62002
      • OSF Saint Anthony's Health Center
    • Barrington, Illinois, United States, 60010
      • Advocate Good Shepherd Hospital
    • Centralia, Illinois, United States, 62801
      • Centralia Oncology Clinic
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60612
      • University of Illinois
    • Crystal Lake, Illinois, United States, 60014
      • AMG Crystal Lake - Oncology
    • Danville, Illinois, United States, 61832
      • Carle at The Riverfront
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Decatur, Illinois, United States, 62526
      • Cancer Care Specialists of Illinois - Decatur
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
    • Effingham, Illinois, United States, 62401
      • Crossroads Cancer Center
    • Effingham, Illinois, United States, 62401
      • Carle Physician Group-Effingham
    • Hines, Illinois, United States, 60141
      • Edward Hines Jr VA Hospital
    • Mattoon, Illinois, United States, 61938
      • Carle Physician Group-Mattoon/Charleston
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • O'Fallon, Illinois, United States, 62269
      • Cancer Care Center of O'Fallon
    • O'Fallon, Illinois, United States, 62269
      • HSHS Saint Elizabeth's Hospital
    • Oak Lawn, Illinois, United States, 60453-2699
      • Advocate Christ Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
    • Rockford, Illinois, United States, 61114
      • UW Health Carbone Cancer Center Rockford
    • Shiloh, Illinois, United States, 62269
      • Memorial Hospital East
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic
    • Springfield, Illinois, United States, 62781
      • Springfield Memorial Hospital
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
  • Indiana
    • Avon, Indiana, United States, 46123
      • IU Health West Hospital
    • Carmel, Indiana, United States, 46032
      • IU Health North Hospital
    • Crown Point, Indiana, United States, 46307
      • Northwest Cancer Center - Main Campus
    • Dyer, Indiana, United States, 46311
      • Northwest Oncology LLC
    • Hobart, Indiana, United States, 46342
      • Northwest Cancer Center - Hobart
    • Hobart, Indiana, United States, 46342
      • Saint Mary Medical Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University/Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital
    • Munster, Indiana, United States, 46321
      • The Community Hospital
    • Munster, Indiana, United States, 46321
      • Women's Diagnostic Center - Munster
    • Valparaiso, Indiana, United States, 46383
      • Northwest Cancer Center - Valparaiso
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic - Ames
    • Cedar Rapids, Iowa, United States, 52403
      • Mercy Hospital
    • Cedar Rapids, Iowa, United States, 52403
      • Oncology Associates at Mercy Medical Center
    • Clive, Iowa, United States, 50325
      • Mercy Cancer Center-West Lakes
    • Clive, Iowa, United States, 50325
      • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
    • Creston, Iowa, United States, 50801
      • Greater Regional Medical Center
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center - Des Moines
    • Des Moines, Iowa, United States, 50314
      • Broadlawns Medical Center
    • Des Moines, Iowa, United States, 50316
      • Iowa Lutheran Hospital
    • Des Moines, Iowa, United States, 50309
      • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    • Des Moines, Iowa, United States, 50314
      • UI Health Care Mission Cancer and Blood - Laurel Clinic
    • West Des Moines, Iowa, United States, 50266-7700
      • Methodist West Hospital
    • West Des Moines, Iowa, United States, 50266
      • Mercy Medical Center-West Lakes
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
    • Lawrence, Kansas, United States, 66044
      • Lawrence Memorial Hospital
    • Overland Park, Kansas, United States, 66210
      • University of Kansas Cancer Center-Overland Park
    • Salina, Kansas, United States, 67401
      • Salina Regional Health Center
    • Topeka, Kansas, United States, 66606
      • University of Kansas Health System Saint Francis Campus
    • Westwood, Kansas, United States, 66205
      • University of Kansas Hospital-Westwood Cancer Center
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospitals Wichita
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Saint Elizabeth Healthcare Edgewood
    • Fort Thomas, Kentucky, United States, 41075
      • Saint Elizabeth Healthcare Fort Thomas
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky/Markey Cancer Center
    • Louisville, Kentucky, United States, 40202
      • The James Graham Brown Cancer Center at University of Louisville
    • Louisville, Kentucky, United States, 40245
      • UofL Health Medical Center Northeast
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • East Jefferson General Hospital
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Science Center
  • Maine
    • Bath, Maine, United States, 04530
      • MaineHealth Coastal Cancer Treatment Center
    • Brewer, Maine, United States, 04412
      • Lafayette Family Cancer Center-EMMC
    • Portland, Maine, United States, 04102
      • MaineHealth Maine Medical Center - Portland
    • Sanford, Maine, United States, 04073
      • MaineHealth Cancer Care Center of York County
    • Scarborough, Maine, United States, 04074
      • MaineHealth Maine Medical Center- Scarborough
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Luminis Health Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Baltimore, Maryland, United States, 21201
      • University of Maryland/Greenebaum Cancer Center
    • Baltimore, Maryland, United States, 21201
      • Veterans Administration Medical Center-Baltimore
    • Bel Air, Maryland, United States, 21014
      • UM Upper Chesapeake Medical Center
    • Columbia, Maryland, United States, 21044
      • Central Maryland Radiation Oncology in Howard County
    • Easton, Maryland, United States, 21601
      • University of Maryland Shore Medical Center at Easton
    • Glen Burnie, Maryland, United States, 21061
      • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Ocean Pines, Maryland, United States, 21811
      • TidalHealth Richard A Henson Cancer Institute
    • Salisbury, Maryland, United States, 21801
      • TidalHealth Peninsula Regional
    • Westminster, Maryland, United States, 21157
      • William E Kahlert Regional Cancer Center/Sinai Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
    • Milford, Massachusetts, United States, 01757
      • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
    • Plymouth, Massachusetts, United States, 02360
      • Beth Israel Deaconess Hospital-Plymouth
    • South Weymouth, Massachusetts, United States, 02190
      • Dana-Farber/Brigham and Women's Cancer Center at South Shore
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
    • Brighton, Michigan, United States, 48114
      • Trinity Health IHA Medical Group Hematology Oncology - Brighton
    • Brighton, Michigan, United States, 48114
      • Trinity Health Medical Center - Brighton
    • Brownstown, Michigan, United States, 48183
      • Henry Ford Cancer Institute-Downriver
    • Canton, Michigan, United States, 48188
      • Trinity Health Medical Center - Canton
    • Chelsea, Michigan, United States, 48118
      • Chelsea Hospital
    • Dearborn, Michigan, United States, 48124
      • Corewell Health Dearborn Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Henry Ford Health Saint John Hospital
    • Farmington Hills, Michigan, United States, 48336
      • Corewell Health Farmington Hills Hospital
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Livonia, Michigan, United States, 48154
      • Trinity Health Saint Mary Mercy Livonia Hospital
    • Pontiac, Michigan, United States, 48341
      • Trinity Health Saint Joseph Mercy Oakland Hospital
    • Pontiac, Michigan, United States, 48341
      • Michigan Healthcare Professionals Pontiac
    • Royal Oak, Michigan, United States, 48073
      • Corewell Health William Beaumont University Hospital
    • Saginaw, Michigan, United States, 48604
      • Oncology Hematology Associates of Saginaw Valley PC
    • Saginaw, Michigan, United States, 48601
      • MyMichigan Medical Center Saginaw
    • Tawas City, Michigan, United States, 48764
      • MyMichigan Medical Center Tawas
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
    • Troy, Michigan, United States, 48085
      • Corewell Health Beaumont Troy Hospital
    • Warren, Michigan, United States, 48093
      • Henry Ford Health Warren Hospital
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital
    • West Branch, Michigan, United States, 48661
      • Saint Mary's Oncology/Hematology Associates of West Branch
    • Ypsilanti, Michigan, United States, 48197
      • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  • Minnesota
    • Bemidji, Minnesota, United States, 56601
      • Sanford Joe Lueken Cancer Center
    • Duluth, Minnesota, United States, 55805
      • Miller-Dwan Hospital
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Health Center
    • Saint Cloud, Minnesota, United States, 56303
      • Coborn Cancer Center at Saint Cloud Hospital
    • Shakopee, Minnesota, United States, 55379
      • Saint Francis Regional Medical Center
  • Mississippi
    • Oxford, Mississippi, United States, 38655
      • Baptist Memorial Hospital and Cancer Center-Oxford
    • Southhaven, Mississippi, United States, 38671
      • Baptist Memorial Hospital and Cancer Center-Desoto
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Saint Francis Medical Center
    • City of Saint Peters, Missouri, United States, 63376
      • Siteman Cancer Center at Saint Peters Hospital
    • Columbia, Missouri, United States, 65212
      • MU Health - University Hospital/Ellis Fischel Cancer Center
    • Creve Coeur, Missouri, United States, 63141
      • Siteman Cancer Center at West County Hospital
    • Farmington, Missouri, United States, 63640
      • Parkland Health Center - Farmington
    • Jefferson City, Missouri, United States, 65109
      • MU Health Care Goldschmidt Cancer Center
    • Joplin, Missouri, United States, 64804
      • Freeman Health System
    • Kansas City, Missouri, United States, 64154
      • University of Kansas Cancer Center - North
    • Lee's Summit, Missouri, United States, 64064
      • University of Kansas Cancer Center - Lee's Summit
    • North Kansas City, Missouri, United States, 64116
      • University of Kansas Cancer Center at North Kansas City Hospital
    • Rolla, Missouri, United States, 65401
      • Phelps Health Delbert Day Cancer Institute
    • Sainte Genevieve, Missouri, United States, 63670
      • Sainte Genevieve County Memorial Hospital
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63129
      • Siteman Cancer Center-South County
    • St Louis, Missouri, United States, 63136
      • Siteman Cancer Center at Christian Hospital
    • St Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • Sullivan, Missouri, United States, 63080
      • Missouri Baptist Sullivan Hospital
    • Sunset Hills, Missouri, United States, 63127
      • BJC Outpatient Center at Sunset Hills
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
    • Butte, Montana, United States, 59701
      • Saint James Community Hospital and Cancer Treatment Center
    • Great Falls, Montana, United States, 59405
      • Benefis Sletten Cancer Institute
    • Kalispell, Montana, United States, 59901
      • Logan Health Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Cancer Partners of Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
    • Omaha, Nebraska, United States, 68124
      • Alegent Health Bergan Mercy Medical Center
  • New Jersey
    • Elizabeth, New Jersey, United States, 07207
      • Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
    • Hamilton, New Jersey, United States, 08690
      • The Cancer Institute of New Jersey Hamilton
    • Long Branch, New Jersey, United States, 07740
      • Monmouth Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
    • Pennington, New Jersey, United States, 08534
      • Capital Health Medical Center-Hopewell
    • Pompton, New Jersey, United States, 07444
      • Chilton Medical Center
    • Somerville, New Jersey, United States, 08876
      • Robert Wood Johnson University Hospital Somerset
    • Summit, New Jersey, United States, 07902
      • Overlook Hospital
    • Toms River, New Jersey, United States, 08755
      • Community Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Lovelace Radiation Oncology
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Cancer Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Camillus, New York, United States, 13031
      • Hematology Oncology Associates of CNY at Camillus
    • Canandiaqua, New York, United States, 14424
      • Sands Cancer Center
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York-East Syracuse
    • Glens Falls, New York, United States, 12801
      • Glens Falls Hospital
    • New York, New York, United States, 10032
      • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14620
      • Highland Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center-Einstein Campus
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Campus
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center-Weiler Hospital
    • Verona, New York, United States, 13478
      • Upstate Cancer Center at Verona
  • North Carolina
    • Albemarle, North Carolina, United States, 28002
      • Atrium Health Stanly/LCI-Albemarle
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center/Levine Cancer Institute
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center
    • Charlotte, North Carolina, United States, 28210
      • Atrium Health Pineville/LCI-Pineville
    • Charlotte, North Carolina, United States, 28262
      • Atrium Health University City/LCI-University
    • Concord, North Carolina, United States, 28025
      • Atrium Health Cabarrus/LCI-Concord
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center
    • Forest City, North Carolina, United States, 28043
      • Levine Cancer Institute - Rutherford
    • Gastonia, North Carolina, United States, 28054
      • CaroMont Regional Medical Center
    • Huntersville, North Carolina, United States, 28078
      • Novant Health Cancer Institute - Huntersville
    • Huntersville, North Carolina, United States, 28078
      • Novant Health Presbyterian Medical Center Huntersville
    • Kernersville, North Carolina, United States, 27284
      • Novant Health Cancer Institute - Kernersville
    • Lincolnton, North Carolina, United States, 28092
      • CaroMont Health - Lincoln Cancer Center
    • Matthews, North Carolina, United States, 28105
      • Matthews Radiation Oncology Center
    • Matthews, North Carolina, United States, 28105
      • Novant Health Cancer Institute - Matthews
    • Monroe, North Carolina, United States, 28112
      • Atrium Health Union/LCI-Union
    • Mooresville, North Carolina, United States, 28117
      • Novant Health Cancer Institute - Mooresville
    • Mount Airy, North Carolina, United States, 27030
      • Novant Health Cancer Institute - Mount Airy
    • New Bern, North Carolina, United States, 28561
      • CarolinaEast Medical Center
    • North Wilkesboro, North Carolina, United States, 28659
      • Novant Health Cancer Institute - Wilkesboro
    • Salisbury, North Carolina, United States, 28144
      • Novant Health Cancer Institute - Rowan
    • Salisbury, North Carolina, United States, 28144
      • Rowan Regional Medical Center
    • Shelby, North Carolina, United States, 28150
      • Atrium Health Cleveland/LCI-Cleveland
    • Stateville, North Carolina, United States, 28625
      • Novant Health Cancer Institute - Statesville
    • Thomasville, North Carolina, United States, 27360
      • Novant Health Cancer Institute - Thomasville
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Sanford Bismarck Medical Center
    • Fargo, North Dakota, United States, 58122
      • Sanford Roger Maris Cancer Center
    • Fargo, North Dakota, United States, 58122
      • Sanford Broadway Medical Center
    • Grand Forks, North Dakota, United States, 58201
      • Altru Cancer Center
  • Ohio
    • Akron, Ohio, United States, 44307
      • Cleveland Clinic Akron General
    • Beachwood, Ohio, United States, 44122
      • UHHS-Chagrin Highlands Medical Center
    • Canton, Ohio, United States, 44708
      • Cleveland Clinic Mercy Hospital
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital South
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Cancer Center-UC Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Cleveland, Ohio, United States, 44106
      • Louis Stokes Cleveland VA Medical Center
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Columbus, Ohio, United States, 43228
      • Doctors Hospital
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Dayton, Ohio, United States, 45415
      • Miami Valley Hospital North
    • Dayton, Ohio, United States, 45409
      • Premier Blood and Cancer Center
    • Delaware, Ohio, United States, 43015
      • Delaware Health Center-Grady Cancer Center
    • Delaware, Ohio, United States, 43015
      • Grady Memorial Hospital
    • Dublin, Ohio, United States, 43016
      • Dublin Methodist Hospital
    • Franklin, Ohio, United States, 45005-1066
      • Atrium Medical Center-Middletown Regional Hospital
    • Greenville, Ohio, United States, 45331
      • Miami Valley Cancer Care and Infusion
    • Grove City, Ohio, United States, 43123
      • Mount Carmel Grove City Hospital
    • Mansfield, Ohio, United States, 44903
      • OhioHealth Mansfield Hospital
    • Marion, Ohio, United States, 43302
      • OhioHealth Marion General Hospital
    • Mentor, Ohio, United States, 44060
      • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Middleburg Heights, Ohio, United States, 44130
      • UH Seidman Cancer Center at Southwest General Hospital
    • Parma, Ohio, United States, 44129
      • University Hospitals Parma Medical Center
    • Perrysburg, Ohio, United States, 43551
      • Mercy Health - Perrysburg Hospital
    • Ravenna, Ohio, United States, 44266
      • University Hospitals Portage Medical Center
    • Toledo, Ohio, United States, 43623
      • Mercy Health - Saint Anne Hospital
    • Troy, Ohio, United States, 45373
      • Upper Valley Medical Center
    • West Chester, Ohio, United States, 45069
      • University of Cincinnati Cancer Center-West Chester
    • Westlake, Ohio, United States, 44145
      • UH Seidman Cancer Center at Saint John Medical Center
    • Westlake, Ohio, United States, 44145
      • UHHS-Westlake Medical Center
    • Zanesville, Ohio, United States, 43701
      • Genesis Healthcare System Cancer Care Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • UPMC-Heritage Valley Health System Beaver
    • Bethlehem, Pennsylvania, United States, 18017
      • Lehigh Valley Hospital - Muhlenberg
    • Broomall, Pennsylvania, United States, 19008
      • Crozer-Keystone Regional Cancer Center at Broomall
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Carlisle, Pennsylvania, United States, 17015
      • Carlisle Regional Cancer Center
    • Chadds Ford, Pennsylvania, United States, 19317
      • Christiana Care Health System-Concord Health Center
    • Chambersburg, Pennsylvania, United States, 17201
      • Chambersburg Hospital
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • East Norriton, Pennsylvania, United States, 19401
      • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
    • East Stroudsburg, Pennsylvania, United States, 18301
      • Pocono Medical Center
    • Ephrata, Pennsylvania, United States, 17522
      • Ephrata Cancer Center
    • Erie, Pennsylvania, United States, 16505
      • UPMC Hillman Cancer Center Erie
    • Farrell, Pennsylvania, United States, 16121
      • UPMC Cancer Center at UPMC Horizon
    • Furlong, Pennsylvania, United States, 18925
      • Fox Chase Cancer Center Buckingham
    • Gettysburg, Pennsylvania, United States, 17325
      • Adams Cancer Center
    • Glen Mills, Pennsylvania, United States, 19342
      • Crozer Regional Cancer Center at Brinton Lake
    • Greensburg, Pennsylvania, United States, 15601
      • UPMC Cancer Centers - Arnold Palmer Pavilion
    • Harrisburg, Pennsylvania, United States, 17109
      • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
    • Johnstown, Pennsylvania, United States, 15901
      • UPMC-Johnstown/John P. Murtha Regional Cancer Center
    • Lebanon, Pennsylvania, United States, 17042
      • Sechler Family Cancer Center
    • Lewisburg, Pennsylvania, United States, 17837
      • Geisinger Medical Oncology-Lewisburg
    • McKeesport, Pennsylvania, United States, 15132
      • UPMC Cancer Center at UPMC McKeesport
    • Mechanicsburg, Pennsylvania, United States, 17050
      • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
    • Media, Pennsylvania, United States, 19063
      • Riddle Memorial Hospital
    • Monroeville, Pennsylvania, United States, 15146
      • UPMC Cancer Center - Monroeville
    • Moon Township, Pennsylvania, United States, 15108
      • UPMC Hillman Cancer Center in Coraopolis
    • Paoli, Pennsylvania, United States, 19301
      • Paoli Memorial Hospital
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC-Magee Womens Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute (UPCI)
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC-Shadyside Hospital
    • Pittsburgh, Pennsylvania, United States, 15215
      • UPMC-Saint Margaret
    • Pittsburgh, Pennsylvania, United States, 15237
      • UPMC-Passavant Hospital
    • Pittsburgh, Pennsylvania, United States, 15243
      • UPMC-Saint Clair Hospital Cancer Center
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group PC-Robert Packer Hospital
    • Seneca, Pennsylvania, United States, 16346
      • UPMC Cancer Center at UPMC Northwest
    • Uniontown, Pennsylvania, United States, 15401
      • UPMC Uniontown Hospital Radiation Oncology
    • Washington, Pennsylvania, United States, 15301
      • UPMC Washington Hospital Radiation Oncology
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley/Henry Cancer Center
    • Williamsport, Pennsylvania, United States, 17701
      • UPMC Susquehanna
    • Williamsport, Pennsylvania, United States, 17754
      • Divine Providence Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
    • York, Pennsylvania, United States, 17403
      • WellSpan Health-York Cancer Center
    • York, Pennsylvania, United States, 17408
      • UPMC Memorial
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Saint Joseph's/Candler - Bluffton Campus
    • Greenville, South Carolina, United States, 29607
      • Saint Francis Cancer Center
    • Greenville, South Carolina, United States, 29601
      • Saint Francis Hospital
    • Greenwood, South Carolina, United States, 29646
      • Self Regional Healthcare
    • Greer, South Carolina, United States, 29651
      • Gibbs Cancer Center-Pelham
    • Hilton Head Island, South Carolina, United States, 29926
      • The Radiation Oncology Center-Hilton Head/Bluffton
    • Rock Hill, South Carolina, United States, 29732
      • Levine Cancer Institute-Rock Hill
    • Rock Hill, South Carolina, United States, 29730
      • Rock Hill Radiation Therapy Center
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • South Dakota
    • Pierre, South Dakota, United States, 57501
      • Avera Cancer Institute at Pierre
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
    • Sioux Falls, South Dakota, United States, 57117-5134
      • Sanford USD Medical Center - Sioux Falls
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center Oncology Clinic
    • Yankton, South Dakota, United States, 57078
      • Avera Cancer Institute at Yankton
  • Tennessee
    • Collierville, Tennessee, United States, 38017
      • Baptist Memorial Hospital and Cancer Center-Collierville
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital and Cancer Center-Memphis
  • Texas
    • Conroe, Texas, United States, 77384
      • MD Anderson in The Woodlands
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • Houston, Texas, United States, 77030
      • Michael E DeBakey VA Medical Center
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Houston, Texas, United States, 77079
      • MD Anderson West Houston
    • League City, Texas, United States, 77573
      • MD Anderson League City
    • San Antonio, Texas, United States, 78229
      • Audie L Murphy VA Hospital
    • Sugar Land, Texas, United States, 77478
      • MD Anderson in Sugar Land
  • Utah
    • Farmington, Utah, United States, 84025
      • Farmington Health Center
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah
    • Salt Lake City, Utah, United States, 84106
      • University of Utah Sugarhouse Health Center
  • Virginia
    • Fishersville, Virginia, United States, 22939
      • Augusta Health Center for Cancer and Blood Disorders
    • Richmond, Virginia, United States, 23235
      • VCU Massey Cancer Center at Stony Point
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Healthcare
    • Parkersburg, West Virginia, United States, 26101
      • Camden Clark Medical Center
  • Wisconsin
    • Antigo, Wisconsin, United States, 54409
      • Langlade Hospital and Cancer Center
    • Appleton, Wisconsin, United States, 54911
      • ThedaCare Regional Cancer Center
    • Appleton, Wisconsin, United States, 54911
      • ThedaCare Regional Medical Center - Appleton
    • Ashland, Wisconsin, United States, 54806
      • Northwest Wisconsin Cancer Center
    • Berlin, Wisconsin, United States, 54923
      • ThedaCare Cancer Care - Berlin
    • Eau Claire, Wisconsin, United States, 54701
      • Marshfield Medical Center-EC Cancer Center
    • Grafton, Wisconsin, United States, 53024
      • Aurora Cancer Care-Grafton
    • Green Bay, Wisconsin, United States, 54311
      • Aurora BayCare Medical Center
    • Kenosha, Wisconsin, United States, 53142
      • Aurora Cancer Care-Kenosha South
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Center
    • Ladysmith, Wisconsin, United States, 54848
      • Marshfield Medical Center - Ladysmith
    • Marinette, Wisconsin, United States, 54143
      • Aurora Bay Area Medical Group-Marinette
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Medical Center-Marshfield
    • Menomonee Falls, Wisconsin, United States, 53051
      • Froedtert Menomonee Falls Hospital
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Aurora Cancer Care-Milwaukee
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora Sinai Medical Center
    • Milwaukee, Wisconsin, United States, 53295
      • Zablocki Veterans Administration Medical Center
    • Minocqua, Wisconsin, United States, 54548
      • Marshfield Medical Center - Minocqua
    • Mukwonago, Wisconsin, United States, 53149
      • ProHealth D N Greenwald Center
    • Neenah, Wisconsin, United States, 54956
      • ThedaCare Regional Medical Center - Neenah
    • New London, Wisconsin, United States, 54961
      • ThedaCare Cancer Care - New London
    • Oak Creek, Wisconsin, United States, 53154
      • Drexel Town Square Health Center
    • Oconomowoc, Wisconsin, United States, 53066
      • ProHealth Oconomowoc Memorial Hospital
    • Oshkosh, Wisconsin, United States, 54904
      • Vince Lombardi Cancer Clinic - Oshkosh
    • Oshkosh, Wisconsin, United States, 54904
      • ThedaCare Cancer Care - Oshkosh
    • Rhinelander, Wisconsin, United States, 54501
      • Aspirus Cancer Care - James Beck Cancer Center
    • Rice Lake, Wisconsin, United States, 54868
      • Marshfield Medical Center-Rice Lake
    • Shawano, Wisconsin, United States, 54166
      • ThedaCare Cancer Care - Shawano
    • Sheboygan, Wisconsin, United States, 53081
      • Vince Lombardi Cancer Clinic-Sheboygan
    • Stevens Point, Wisconsin, United States, 54482
      • Marshfield Medical Center-River Region at Stevens Point
    • Stevens Point, Wisconsin, United States, 54481
      • Aspirus Cancer Care - Stevens Point
    • Summit, Wisconsin, United States, 53066
      • Aurora Medical Center in Summit
    • Two Rivers, Wisconsin, United States, 54241
      • Vince Lombardi Cancer Clinic-Two Rivers
    • Waukesha, Wisconsin, United States, 53188
      • UW Cancer Center at ProHealth Care
    • Waupaca, Wisconsin, United States, 54981
      • ThedaCare Cancer Care - Waupaca
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Regional Cancer Center
    • West Allis, Wisconsin, United States, 53227
      • Aurora West Allis Medical Center
    • West Bend, Wisconsin, United States, 53095
      • Froedtert West Bend Hospital/Kraemer Cancer Center
    • Weston, Wisconsin, United States, 54476
      • Marshfield Medical Center - Weston
    • Wisconsin Rapids, Wisconsin, United States, 54494
      • Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC)
• Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease
• Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. Patients with limited-stage (LS)-SCLC must have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including stereotactic body radiation therapy [SBRT] for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not required. Patients with extensive-stage (ES)-SCLC must have completed platinum-based chemotherapy either with or without thoracic radiotherapy at the discretion of the treating physician
• All adverse events from prior treatment must have resolved to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) prior to randomization
• Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (computed tomography [CT] or positron emission tomography [PET]/CT including the chest and abdomen) must be performed within 28 days prior to randomization
• No more than 8 weeks may have elapsed between day 1 of the last cycle of chemotherapy and randomization
• Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis
• Patient must have Zubrod performance status of 0-2
• Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
• Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
• Patient must not have other metastatic malignancies requiring current active treatment

• Patient must not have any severe active comorbidities, defined as follows:

  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
  • Transmural myocardial infarction within 6 months prior to randomization
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
  • Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization
  • Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease

  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter

    • Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 16 weeks prior to randomization
    • Note also that HIV testing is not required for eligibility for this protocol
• Patient must not be pregnant because of fetal risks from radiation exposure. Men must have agreed to use an effective contraceptive method during PCI and for six months after completing PCI. Women of reproductive potential must have agreed to use an effective contraceptive method during PCI. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• Patients who speak and understand English or French must agree to participate in cognitive function testing
• Patient must be offered the opportunity to have specimens submitted for banking
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) randomization process the treating institution?s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (PCI, MRI); Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Radiation: Prophylactic Cranial Irradiation; Undergo PCI; Other Names: PCI
Experimental: Arm II (MRI); Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).	From the date of registration to date of death due to any cause, assessed up to 2 years after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive failure-free survival (CFFS)	The comparison of CFFS up to 12 months between the arms will be done using a 1-sided 5% level log-rank test.	Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization
CFFS rate	There will be a comparison of the CFFS rates between the arms at each of the assessment times and the cumulative incidence of cognitive failure, evaluating death as a competing risk. The CFFS rates at the landmark times will be estimated using the method of Kaplan-Meier and the difference in rates will be evaluated using a 90% confidence interval using Greenwood?s formula.	Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization
Cumulative incidence of cognitive failure	The cumulative incidence of cognitive failure in the presence of the competing risk of death will be estimated used the method of Fine and Gray.	Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization
OS in an "as-treated" analysis	The comparison of OS in the ?as-treated? analysis will be done as described for the primary analysis, however patients will be categorized per treatment received (patients who do not accept their randomized assignment will be analyzed per treatment received). The number of patients not accepting the randomized assignment will also be summarized.	From the date of registration to date of death due to any cause, assessed up to 2 years after randomization. Patients will be seen at day 90, 180, 270, 360, 540, and 720
Brain metastases-free survival (BMFS)	This will be estimated using the method of Kaplan-Meier and comparisons will be done using a log-rank test at the 1-sided 0.05 level. Hazard ratios and associated confidence intervals will be estimated using a Cox Proportional hazards model. Confidence intervals for medians will be estimated using the method of Brookmeyer-Crowley.	Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720
Incidence of adverse events	Binary proportions and associated confidence intervals will be estimated.	Up to 2 years after randomization. Patients will be assessed for adverse event after PCI (for patients on PCI + MRI arm) and at month 3 (all patients)

Collaborators and Investigators

• Sponsor: SWOG Cancer Research Network
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Chad G Rusthoven, SWOG Cancer Research Network

Publications and helpful links

General Publications

• Schneiders FL, Senan S. New strategies for patients with limited-stage small-cell lung cancer. Lancet Respir Med. 2024 Oct;12(10):748-750. doi: 10.1016/S2213-2600(24)00223-6. Epub 2024 Aug 12. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Actual): March 17, 2026
• Study Completion (Estimated): November 15, 2029

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: S1827 (Other Identifier: CTEP); U10CA180888 (U.S. NIH Grant/Contract); NCI-2019-05338 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes