SWOG 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

May 2, 2023 updated by: SWOG Cancer Research Network

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

Recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

668

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Victoria, British Columbia, Canada, V8R 6V5
    - Recruiting
    - BCCA-Vancouver Island Cancer Centre
    - Contact:
      
      Site Public Contact
      
      Phone Number: 604-877-6010
    - Principal Investigator:
      
      Julianna Caon
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Recruiting
    - CancerCare Manitoba
    - Principal Investigator:
      
      Bashir M. Bashir
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Recruiting
    - Atlantic Health Sciences Corporation-Saint John Regional Hospital
    - Principal Investigator:
      
      Farah Naz
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - Suspended
    - Doctor H. Bliss Murphy Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Recruiting
    - Juravinski Cancer Centre at Hamilton Health Sciences
    - Contact:
      
      Site Public Contact
      
      Phone Number: 905-387-9495
    - Principal Investigator:
      
      Anand Swaminath
  - Oshawa, Ontario, Canada, L1G 2B9
    - Recruiting
    - Lakeridge Health Oshawa
    - Contact:
      
      Site Public Contact
      
      Phone Number: 4258 905-576-8711
    - Principal Investigator:
      
      Joel Broomfield
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Odette Cancer Centre- Sunnybrook Health Sciences Centre
    - Principal Investigator:
      
      Alexander V. Louie
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - University Health Network-Princess Margaret Hospital
    - Principal Investigator:
      
      Alexander Y. Sun
- Quebec
  - Montreal, Quebec, Canada, H3H 2R9
    - Recruiting
    - The Research Institute of the McGill University Health Centre (MUHC)
    - Contact:
      
      Site Public Contact
      
      Phone Number: 48354 514-934-1934
      
      Email: evelyn.ortega@muhc.mcgill.ca
    - Principal Investigator:
      
      Bassam S. Abdulkarim
  - Quebec City, Quebec, Canada, G1R 2J6
    - Recruiting
    - CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
    - Contact:
      
      Site Public Contact
      
      Email: rechclinique@crchuq.ulaval.ca
    - Principal Investigator:
      
      Caroline Lavoie
  - Trois-Rivieres, Quebec, Canada, G8Z 3R9
    - Recruiting
    - Centre Hospitalier Regional de Trois-Rivieres
    - Principal Investigator:
      
      Francois Vincent
    - Contact:
      
      Site Public Contact
      
      Phone Number: 64399 819-697-3333
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Recruiting
    - Allan Blair Cancer Centre
    - Principal Investigator:
      
      Nelson Leong
Korea, Republic of
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
    - Recruiting
    - National Cancer Center-Korea
    - Principal Investigator:
      
      Beung-chul Ahn
Mexico
- Tlalpan
  - Mexico City, Tlalpan, Mexico, 14080
    - Recruiting
    - Instituto Nacional De Cancerologia de Mexico
    - Contact:
      
      Site Public Contact
      
      Phone Number: (52) 5628-0400
    - Principal Investigator:
      
      Oscar G. Arrieta-Rodriguez
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Active, not recruiting
    - University of Alabama at Birmingham Cancer Center
- Arizona
  - Tucson, Arizona, United States, 85719
    - Active, not recruiting
    - University of Arizona Cancer Center-North Campus
  - Tucson, Arizona, United States, 85704
    - Active, not recruiting
    - University of Arizona Cancer Center-Orange Grove Campus
- California
  - Duarte, California, United States, 91010
    - Recruiting
    - City of Hope Comprehensive Cancer Center
    - Principal Investigator:
      
      Arya Amini
  - Loma Linda, California, United States, 92357
    - Recruiting
    - Veterans Affairs Loma Linda Healthcare System
    - Principal Investigator:
      
      Steven B. Hardin
  - Long Beach, California, United States, 90822
    - Recruiting
    - Tibor Rubin VA Medical Center
  - Los Angeles, California, United States, 90033
    - Recruiting
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Recruiting
    - Los Angeles County-USC Medical Center
  - Sacramento, California, United States, 95817
    - Active, not recruiting
    - University of California Davis Comprehensive Cancer Center
  - San Francisco, California, United States, 94121
    - Recruiting
    - Veterans Affairs Medical Center - San Francisco
  - South Pasadena, California, United States, 91030
    - Recruiting
    - City of Hope South Pasadena
    - Principal Investigator:
      
      Arya Amini
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado Hospital
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Rocky Mountain Regional VA Medical Center
  - Colorado Springs, Colorado, United States, 80909
    - Recruiting
    - UCHealth Memorial Hospital Central
  - Colorado Springs, Colorado, United States, 80920
    - Recruiting
    - Memorial Hospital North
  - Fort Collins, Colorado, United States, 80524
    - Recruiting
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Recruiting
    - Cancer Care and Hematology-Fort Collins
  - Greeley, Colorado, United States, 80631
    - Recruiting
    - North Colorado Medical Center
  - Greeley, Colorado, United States, 80631
    - Recruiting
    - UCHealth Greeley Hospital
  - Highlands Ranch, Colorado, United States, 80129
    - Recruiting
    - UCHealth Highlands Ranch Hospital
  - Loveland, Colorado, United States, 80539
    - Recruiting
    - McKee Medical Center
  - Loveland, Colorado, United States, 80538
    - Recruiting
    - Medical Center of the Rockies
- Connecticut
  - Greenwich, Connecticut, United States, 06830
    - Recruiting
    - Smilow Cancer Hospital Care Center at Greenwich
  - Guilford, Connecticut, United States, 06437
    - Recruiting
    - Smilow Cancer Hospital Care Center - Guiford
  - Hamden, Connecticut, United States, 06518
    - Recruiting
    - Smilow Cancer Hospital-Hamden Care Center
  - New Haven, Connecticut, United States, 06520
    - Recruiting
    - Yale University
  - Trumbull, Connecticut, United States, 06611
    - Recruiting
    - Smilow Cancer Hospital Care Center-Trumbull
  - Waterford, Connecticut, United States, 06385
    - Recruiting
    - Smilow Cancer Hospital Care Center - Waterford
  - West Haven, Connecticut, United States, 06516
    - Recruiting
    - Veterans Affairs Connecticut Healthcare System-West Haven Campus
- Delaware
  - Frankford, Delaware, United States, 19945
    - Active, not recruiting
    - Beebe South Coastal Health Campus
  - Newark, Delaware, United States, 19713
    - Active, not recruiting
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Active, not recruiting
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Active, not recruiting
    - Christiana Care Health System-Christiana Hospital
  - Rehoboth Beach, Delaware, United States, 19971
    - Active, not recruiting
    - Beebe Health Campus
- Florida
  - Atlantis, Florida, United States, 33462
    - Recruiting
    - John Fitzgerald Kennedy Medical Center
    - Contact:
      
      Site Public Contact
      
      Phone Number: 561-964-2662
    - Principal Investigator:
      
      Georges F. Hatoum
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - Boca Raton Regional Hospital
    - Principal Investigator:
      
      Samuel M. Richter
  - Clearwater, Florida, United States, 33756
    - Recruiting
    - Morton Plant Hospital
    - Contact:
      
      Site Public Contact
      
      Phone Number: 855-314-8646
    - Principal Investigator:
      
      Ronica H. Nanda
  - Coral Gables, Florida, United States, 33146
    - Recruiting
    - UM Sylvester Comprehensive Cancer Center at Coral Gables
  - Deerfield Beach, Florida, United States, 33442
    - Recruiting
    - UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  - Gainesville, Florida, United States, 32610
    - Active, not recruiting
    - University of Florida Health Science Center - Gainesville
  - Miami, Florida, United States, 33136
    - Recruiting
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Tampa, Florida, United States, 33612
    - Suspended
    - Moffitt Cancer Center
- Georgia
  - Alpharetta, Georgia, United States, 30005
    - Suspended
    - Northside Hospital-Alpharetta
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Northside Hospital
  - Atlanta, Georgia, United States, 30322
    - Not yet recruiting
    - Emory University Hospital/Winship Cancer Institute
    - Contact:
      
      Drew Moghanaki
      
      Email: drew.moghanaki@emory.edu
    - Principal Investigator:
      
      Drew Moghanaki
  - Augusta, Georgia, United States, 30912
    - Recruiting
    - Augusta University Medical Center
  - Canton, Georgia, United States, 30115
    - Recruiting
    - Northside Hospital-Cherokee
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - John B Amos Cancer Center
    - Contact:
      
      Site Public Contact
      
      Phone Number: 706-478-7968
      
      Email: cdean@iacthealth.com
    - Principal Investigator:
      
      Andrew W. Pippas
  - Cumming, Georgia, United States, 30041
    - Recruiting
    - Northside Hospital-Forsyth
  - Decatur, Georgia, United States, 30033
    - Active, not recruiting
    - Atlanta VA Medical Center
  - Savannah, Georgia, United States, 31405
    - Recruiting
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Recruiting
    - Hawaii Cancer Care - Savio
  - 'Aiea, Hawaii, United States, 96701
    - Recruiting
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Recruiting
    - The Cancer Center of Hawaii-Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Recruiting
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, United States, 96813
    - Recruiting
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, United States, 96813
    - Recruiting
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Recruiting
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96817
    - Recruiting
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96817
    - Recruiting
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, United States, 96817
    - Recruiting
    - The Cancer Center of Hawaii-Liliha
- Illinois
  - Alton, Illinois, United States, 62002
    - Recruiting
    - Alton Memorial Hospital
    - Contact:
      
      Site Public Contact
      
      Phone Number: 618-463-7323
    - Principal Investigator:
      
      Shahed N. Badiyan
  - Chicago, Illinois, United States, 60612
    - Active, not recruiting
    - University of Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern University
    - Principal Investigator:
      
      Mohamed E. Abazeed
  - Chicago, Illinois, United States, 60612
    - Active, not recruiting
    - Rush University Medical Center
  - Danville, Illinois, United States, 61832
    - Recruiting
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Recruiting
    - Cancer Care Specialists of Illinois - Decatur
  - Decatur, Illinois, United States, 62526
    - Recruiting
    - Decatur Memorial Hospital
  - Effingham, Illinois, United States, 62401
    - Recruiting
    - Carle Physician Group-Effingham
  - Hines, Illinois, United States, 60141
    - Recruiting
    - Edward Hines Jr VA Hospital
    - Principal Investigator:
      
      James S. Welsh
  - Mattoon, Illinois, United States, 61938
    - Recruiting
    - Carle Physician Group-Mattoon/Charleston
  - Maywood, Illinois, United States, 60153
    - Recruiting
    - Loyola University Medical Center
  - Peoria, Illinois, United States, 61636
    - Recruiting
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61637
    - Recruiting
    - OSF Saint Francis Medical Center
  - Shiloh, Illinois, United States, 62269
    - Recruiting
    - Memorial Hospital East
    - Contact:
      
      Site Public Contact
      
      Phone Number: 314-747-9912
      
      Email: dschwab@wustl.edu
    - Principal Investigator:
      
      Shahed N. Badiyan
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Springfield Clinic
  - Springfield, Illinois, United States, 62781
    - Recruiting
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Recruiting
    - Carle Cancer Center
- Indiana
  - Crown Point, Indiana, United States, 46307
    - Recruiting
    - Northwest Cancer Center - Main Campus
  - Dyer, Indiana, United States, 46311
    - Recruiting
    - Northwest Oncology LLC
  - Hobart, Indiana, United States, 46342
    - Recruiting
    - Northwest Cancer Center - Hobart
  - Hobart, Indiana, United States, 46342
    - Recruiting
    - Saint Mary Medical Center
  - Munster, Indiana, United States, 46321
    - Recruiting
    - The Community Hospital
  - Munster, Indiana, United States, 46321
    - Recruiting
    - Women's Diagnostic Center - Munster
  - Valparaiso, Indiana, United States, 46383
    - Recruiting
    - Northwest Cancer Center - Valparaiso
- Iowa
  - Ames, Iowa, United States, 50010
    - Recruiting
    - McFarland Clinic PC - Ames
  - Cedar Rapids, Iowa, United States, 52403
    - Recruiting
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Recruiting
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Recruiting
    - Medical Oncology and Hematology Associates-West Des Moines
  - Clive, Iowa, United States, 50325
    - Recruiting
    - Mercy Cancer Center-West Lakes
  - Creston, Iowa, United States, 50801
    - Recruiting
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50309
    - Recruiting
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50314
    - Recruiting
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50314
    - Recruiting
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50314
    - Recruiting
    - Mission Cancer and Blood - Laurel
  - Des Moines, Iowa, United States, 50309
    - Recruiting
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50316
    - Recruiting
    - Iowa Lutheran Hospital
  - West Des Moines, Iowa, United States, 50266
    - Recruiting
    - Mercy Medical Center-West Lakes
  - West Des Moines, Iowa, United States, 50266-7700
    - Recruiting
    - Methodist West Hospital
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - University of Kansas Cancer Center
  - Lawrence, Kansas, United States, 66044
    - Suspended
    - Lawrence Memorial Hospital
  - Overland Park, Kansas, United States, 66210
    - Recruiting
    - University of Kansas Cancer Center-Overland Park
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, United States, 66205
    - Recruiting
    - University of Kansas Hospital-Westwood Cancer Center
  - Wichita, Kansas, United States, 67214
    - Recruiting
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, United States, 67214
    - Recruiting
    - Wesley Medical Center
- Kentucky
  - Edgewood, Kentucky, United States, 41017
    - Recruiting
    - Saint Elizabeth Healthcare Edgewood
    - Principal Investigator:
      
      Bradley J. Huth
  - Fort Thomas, Kentucky, United States, 41075
    - Recruiting
    - Saint Elizabeth Fort Thomas
    - Principal Investigator:
      
      Bradley J. Huth
  - Lexington, Kentucky, United States, 40536
    - Active, not recruiting
    - University of Kentucky/Markey Cancer Center
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - The James Graham Brown Cancer Center at University of Louisville
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - East Jefferson General Hospital
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - University Medical Center New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - Louisiana State University Health Science Center
- Maine
  - Bath, Maine, United States, 04530
    - Recruiting
    - MaineHealth Coastal Cancer Treatment Center
  - Brewer, Maine, United States, 04412
    - Recruiting
    - Lafayette Family Cancer Center-EMMC
  - Portland, Maine, United States, 04102
    - Recruiting
    - Maine Medical Center-Bramhall Campus
  - Sanford, Maine, United States, 04073
    - Recruiting
    - MaineHealth Cancer Care Center of York County
  - Scarborough, Maine, United States, 04074
    - Recruiting
    - Maine Medical Center- Scarborough Campus
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Active, not recruiting
    - Anne Arundel Medical Center
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - University of Maryland/Greenebaum Cancer Center
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - Veterans Administration Medical Center-Baltimore
    - Contact:
      
      Site Public Contact
      
      Phone Number: 800-463-6295
    - Principal Investigator:
      
      Christine Bang
  - Bel Air, Maryland, United States, 21014
    - Recruiting
    - UM Upper Chesapeake Medical Center
  - Columbia, Maryland, United States, 21044
    - Recruiting
    - Central Maryland Radiation Oncology in Howard County
  - Easton, Maryland, United States, 21601
    - Recruiting
    - University of Maryland Shore Medical Center at Easton
    - Principal Investigator:
      
      John P. Mastandrea
  - Glen Burnie, Maryland, United States, 21061
    - Recruiting
    - UM Baltimore Washington Medical Center/Tate Cancer Center
  - Ocean Pines, Maryland, United States, 21811
    - Recruiting
    - TidalHealth Richard A Henson Cancer Institute
    - Principal Investigator:
      
      Zeinab Abou Yehia
  - Salisbury, Maryland, United States, 21801
    - Recruiting
    - TidalHealth Peninsula Regional
    - Principal Investigator:
      
      Zeinab Abou Yehia
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Brigham and Women's Hospital
    - Principal Investigator:
      
      David E. Kozono
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana-Farber Cancer Institute
    - Principal Investigator:
      
      David E. Kozono
  - Boston, Massachusetts, United States, 02118
    - Recruiting
    - Boston Medical Center
    - Principal Investigator:
      
      Kimberley S. Mak
  - Burlington, Massachusetts, United States, 01805
    - Recruiting
    - Lahey Hospital and Medical Center
    - Principal Investigator:
      
      Asa J. Nixon
  - Milford, Massachusetts, United States, 01757
    - Suspended
    - Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
  - Plymouth, Massachusetts, United States, 02360
    - Recruiting
    - Beth Israel Deaconess Hospital-Plymouth
  - South Weymouth, Massachusetts, United States, 02190
    - Suspended
    - Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Recruiting
    - Saint Joseph Mercy Hospital
  - Brighton, Michigan, United States, 48114
    - Recruiting
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - Recruiting
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brownstown, Michigan, United States, 48183
    - Active, not recruiting
    - Henry Ford Cancer Institute-Downriver
  - Canton, Michigan, United States, 48188
    - Recruiting
    - Saint Joseph Mercy Canton
  - Chelsea, Michigan, United States, 48118
    - Recruiting
    - Saint Joseph Mercy Chelsea
  - Dearborn, Michigan, United States, 48124
    - Recruiting
    - Beaumont Hospital - Dearborn
  - Detroit, Michigan, United States, 48236
    - Recruiting
    - Ascension Saint John Hospital
  - Detroit, Michigan, United States, 48202
    - Active, not recruiting
    - Henry Ford Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Recruiting
    - West Michigan Cancer Center
  - Livonia, Michigan, United States, 48154
    - Recruiting
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Pontiac, Michigan, United States, 48341
    - Recruiting
    - 21st Century Oncology-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Recruiting
    - Saint Joseph Mercy Oakland
  - Royal Oak, Michigan, United States, 48073
    - Recruiting
    - William Beaumont Hospital-Royal Oak
  - Saginaw, Michigan, United States, 48601
    - Recruiting
    - Ascension Saint Mary's Hospital
  - Saginaw, Michigan, United States, 48604
    - Recruiting
    - Oncology Hematology Associates of Saginaw Valley PC
  - Tawas City, Michigan, United States, 48764
    - Recruiting
    - Ascension Saint Joseph Hospital
  - Traverse City, Michigan, United States, 49684
    - Recruiting
    - Munson Medical Center
  - Troy, Michigan, United States, 48085
    - Recruiting
    - William Beaumont Hospital - Troy
  - Warren, Michigan, United States, 48093
    - Recruiting
    - Saint John Macomb-Oakland Hospital
  - West Bloomfield, Michigan, United States, 48322
    - Active, not recruiting
    - Henry Ford West Bloomfield Hospital
  - West Branch, Michigan, United States, 48661
    - Recruiting
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Ypsilanti, Michigan, United States, 48197
    - Recruiting
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Recruiting
    - Sanford Joe Lueken Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Recruiting
    - Miller-Dwan Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Recruiting
    - Hennepin County Medical Center
- Mississippi
  - Oxford, Mississippi, United States, 38655
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Oxford
  - Southhaven, Mississippi, United States, 38671
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Recruiting
    - Saint Francis Medical Center
  - Columbia, Missouri, United States, 65212
    - Recruiting
    - University of Missouri - Ellis Fischel
  - Creve Coeur, Missouri, United States, 63141
    - Recruiting
    - Siteman Cancer Center at West County Hospital
    - Principal Investigator:
      
      Shahed N. Badiyan
  - Farmington, Missouri, United States, 63640
    - Recruiting
    - Parkland Health Center - Farmington
  - Joplin, Missouri, United States, 64804
    - Recruiting
    - Freeman Health System
  - Kansas City, Missouri, United States, 64154
    - Recruiting
    - University of Kansas Cancer Center - North
  - Lee's Summit, Missouri, United States, 64064
    - Recruiting
    - University of Kansas Cancer Center - Lee's Summit
  - North Kansas City, Missouri, United States, 64116
    - Recruiting
    - University of Kansas Cancer Center at North Kansas City Hospital
  - Rolla, Missouri, United States, 65401
    - Recruiting
    - Delbert Day Cancer Institute at PCRMC
  - Saint Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University School of Medicine
    - Principal Investigator:
      
      Shahed N. Badiyan
  - Saint Louis, Missouri, United States, 63131
    - Recruiting
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63129
    - Recruiting
    - Siteman Cancer Center-South County
    - Principal Investigator:
      
      Shahed N. Badiyan
  - Saint Louis, Missouri, United States, 63136
    - Recruiting
    - Siteman Cancer Center at Christian Hospital
    - Principal Investigator:
      
      Shahed N. Badiyan
  - Saint Peters, Missouri, United States, 63376
    - Recruiting
    - Siteman Cancer Center at Saint Peters Hospital
    - Principal Investigator:
      
      Shahed N. Badiyan
  - Sainte Genevieve, Missouri, United States, 63670
    - Recruiting
    - Sainte Genevieve County Memorial Hospital
  - Sullivan, Missouri, United States, 63080
    - Recruiting
    - Missouri Baptist Sullivan Hospital
- Montana
  - Butte, Montana, United States, 59701
    - Active, not recruiting
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Recruiting
    - Benefis Healthcare- Sletten Cancer Institute
  - Kalispell, Montana, United States, 59901
    - Recruiting
    - Kalispell Regional Medical Center
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Recruiting
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68124
    - Recruiting
    - Alegent Health Bergan Mercy Medical Center
- New Jersey
  - Elizabeth, New Jersey, United States, 07207
    - Recruiting
    - Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
    - Contact:
      
      Site Public Contact
      
      Phone Number: 908-994-8000
    - Principal Investigator:
      
      Matthew P. Deek
  - Hamilton, New Jersey, United States, 08690
    - Recruiting
    - The Cancer Institute of New Jersey Hamilton
    - Principal Investigator:
      
      Matthew P. Deek
  - New Brunswick, New Jersey, United States, 08903
    - Recruiting
    - Rutgers Cancer Institute of New Jersey
    - Principal Investigator:
      
      Matthew P. Deek
  - Pennington, New Jersey, United States, 08534
    - Recruiting
    - Capital Health Medical Center-Hopewell
  - Pompton, New Jersey, United States, 07444
    - Recruiting
    - Chilton Medical Center
    - Principal Investigator:
      
      Kenneth Blank
  - Somerville, New Jersey, United States, 08876
    - Recruiting
    - Robert Wood Johnson University Hospital Somerset
    - Principal Investigator:
      
      Matthew P. Deek
  - Summit, New Jersey, United States, 07902
    - Recruiting
    - Overlook Hospital
    - Principal Investigator:
      
      Kenneth Blank
  - Toms River, New Jersey, United States, 08755
    - Recruiting
    - Community Medical Center
    - Principal Investigator:
      
      Matthew P. Deek
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Recruiting
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87109
    - Recruiting
    - Lovelace Radiation Oncology
- New York
  - Bronx, New York, United States, 10461
    - Active, not recruiting
    - Montefiore Medical Center-Einstein Campus
  - Bronx, New York, United States, 10461
    - Active, not recruiting
    - Montefiore Medical Center-Weiler Hospital
  - Bronx, New York, United States, 10467
    - Active, not recruiting
    - Montefiore Medical Center - Moses Campus
  - Buffalo, New York, United States, 14263
    - Recruiting
    - Roswell Park Cancer Institute
    - Principal Investigator:
      
      Dheerendra Prasad
  - Canandaigua, New York, United States, 14424
    - Active, not recruiting
    - Sands Cancer Center
  - Glens Falls, New York, United States, 12801
    - Recruiting
    - Glens Falls Hospital
  - New York, New York, United States, 10032
    - Recruiting
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    - Principal Investigator:
      
      Simon K. Cheng
  - Rochester, New York, United States, 14642
    - Active, not recruiting
    - University of Rochester
  - Rochester, New York, United States, 14620
    - Active, not recruiting
    - Highland Hospital
  - Stony Brook, New York, United States, 11794
    - Recruiting
    - Stony Brook University Medical Center
  - Syracuse, New York, United States, 13210
    - Recruiting
    - State University of New York Upstate Medical University
- North Carolina
  - Charlotte, North Carolina, United States, 28203
    - Recruiting
    - Carolinas Medical Center/Levine Cancer Institute
  - Durham, North Carolina, United States, 27705
    - Active, not recruiting
    - Durham VA Medical Center
  - Gastonia, North Carolina, United States, 28054
    - Recruiting
    - CaroMont Regional Medical Center
  - New Bern, North Carolina, United States, 28561
    - Recruiting
    - CarolinaEast Medical Center
    - Principal Investigator:
      
      Seth M. Miller
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Recruiting
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Recruiting
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58122
    - Recruiting
    - Sanford Roger Maris Cancer Center
  - Grand Forks, North Dakota, United States, 58201
    - Recruiting
    - Altru Cancer Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Recruiting
    - Cleveland Clinic Akron General
    - Principal Investigator:
      
      Ashok Ramalingam
  - Beachwood, Ohio, United States, 44122
    - Recruiting
    - UHHS-Chagrin Highlands Medical Center
    - Principal Investigator:
      
      Tithi Biswas
  - Canton, Ohio, United States, 44708
    - Recruiting
    - Cleveland Clinic Mercy Hospital
    - Principal Investigator:
      
      Edward J. Walsh
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - Case Western Reserve University
    - Principal Investigator:
      
      Tithi Biswas
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - Louis Stokes Cleveland VA Medical Center
    - Contact:
      
      Site Public Contact
      
      Email: holly.henry@va.gov
    - Principal Investigator:
      
      Aryavarta M. Kumar
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Ohio State University Comprehensive Cancer Center
  - Dublin, Ohio, United States, 43016
    - Recruiting
    - Dublin Methodist Hospital
  - Grove City, Ohio, United States, 43123
    - Recruiting
    - Mount Carmel Grove City Hospital
  - Mentor, Ohio, United States, 44060
    - Recruiting
    - UH Seidman Cancer Center at Lake Health Mentor Campus
    - Principal Investigator:
      
      Tithi Biswas
  - Middleburg Heights, Ohio, United States, 44130
    - Recruiting
    - UH Seidman Cancer Center at Southwest General Hospital
    - Principal Investigator:
      
      Tithi Biswas
  - Parma, Ohio, United States, 44129
    - Recruiting
    - University Hospitals Parma Medical Center
    - Principal Investigator:
      
      Tithi Biswas
  - Perrysburg, Ohio, United States, 43551
    - Recruiting
    - Mercy Health Perrysburg Cancer Center
  - Ravenna, Ohio, United States, 44266
    - Recruiting
    - University Hospitals Portage Medical Center
    - Principal Investigator:
      
      Tithi Biswas
  - Toledo, Ohio, United States, 43623
    - Recruiting
    - Mercy Health - Saint Anne Hospital
  - West Chester, Ohio, United States, 45069
    - Recruiting
    - University of Cincinnati Cancer Center-West Chester
  - Westlake, Ohio, United States, 44145
    - Recruiting
    - UH Seidman Cancer Center at Saint John Medical Center
    - Principal Investigator:
      
      Tithi Biswas
  - Westlake, Ohio, United States, 44145
    - Recruiting
    - UHHS-Westlake Medical Center
    - Principal Investigator:
      
      Tithi Biswas
  - Zanesville, Ohio, United States, 43701
    - Recruiting
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - University of Oklahoma Health Sciences Center
- Pennsylvania
  - Beaver, Pennsylvania, United States, 15009
    - Recruiting
    - UPMC-Heritage Valley Health System Beaver
  - Broomall, Pennsylvania, United States, 19008
    - Recruiting
    - Crozer-Keystone Regional Cancer Center at Broomall
  - Carlisle, Pennsylvania, United States, 17015
    - Recruiting
    - Carlisle Regional Cancer Center
  - Chadds Ford, Pennsylvania, United States, 19317
    - Active, not recruiting
    - Christiana Care Health System-Concord Health Center
  - Danville, Pennsylvania, United States, 17822
    - Recruiting
    - Geisinger Medical Center
  - East Norriton, Pennsylvania, United States, 19401
    - Active, not recruiting
    - Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
  - Ephrata, Pennsylvania, United States, 17522
    - Recruiting
    - Ephrata Cancer Center
  - Erie, Pennsylvania, United States, 16505
    - Recruiting
    - UPMC Hillman Cancer Center Erie
  - Farrell, Pennsylvania, United States, 16121
    - Recruiting
    - UPMC Cancer Center at UPMC Horizon
  - Furlong, Pennsylvania, United States, 18925
    - Active, not recruiting
    - Fox Chase Cancer Center Buckingham
  - Gettysburg, Pennsylvania, United States, 17325
    - Recruiting
    - Adams Cancer Center
  - Glen Mills, Pennsylvania, United States, 19342
    - Recruiting
    - Crozer Regional Cancer Center at Brinton Lake
  - Greensburg, Pennsylvania, United States, 15601
    - Recruiting
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Harrisburg, Pennsylvania, United States, 17109
    - Recruiting
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Johnstown, Pennsylvania, United States, 15901
    - Recruiting
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - Lebanon, Pennsylvania, United States, 17042
    - Recruiting
    - Sechler Family Cancer Center
  - Lewisburg, Pennsylvania, United States, 17837
    - Recruiting
    - Geisinger Medical Oncology-Lewisburg
  - McKeesport, Pennsylvania, United States, 15132
    - Suspended
    - UPMC Cancer Center at UPMC McKeesport
  - Mechanicsburg, Pennsylvania, United States, 17050
    - Recruiting
    - UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  - Monroeville, Pennsylvania, United States, 15146
    - Recruiting
    - UPMC Cancer Center - Monroeville
  - Moon, Pennsylvania, United States, 15108
    - Recruiting
    - UPMC Hillman Cancer Center in Coraopolis
  - Paoli, Pennsylvania, United States, 19301
    - Recruiting
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Active, not recruiting
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19140
    - Active, not recruiting
    - Temple University Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - Recruiting
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - UPMC-Magee Womens Hospital
  - Pittsburgh, Pennsylvania, United States, 15215
    - Recruiting
    - UPMC-Saint Margaret
  - Pittsburgh, Pennsylvania, United States, 15237
    - Recruiting
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - Recruiting
    - UPMC-Saint Clair Hospital Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15232
    - Recruiting
    - UPMC-Shadyside Hospital
  - Sayre, Pennsylvania, United States, 18840
    - Recruiting
    - Guthrie Medical Group PC-Robert Packer Hospital
  - Seneca, Pennsylvania, United States, 16346
    - Recruiting
    - UPMC Cancer Center at UPMC Northwest
  - Uniontown, Pennsylvania, United States, 15401
    - Recruiting
    - UPMC Uniontown Hospital Radiation Oncology
  - Washington, Pennsylvania, United States, 15301
    - Recruiting
    - UPMC Washington Hospital Radiation Oncology
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Recruiting
    - Geisinger Wyoming Valley/Henry Cancer Center
  - Williamsport, Pennsylvania, United States, 17701
    - Recruiting
    - UPMC Susquehanna
  - Wynnewood, Pennsylvania, United States, 19096
    - Recruiting
    - Lankenau Medical Center
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - WellSpan Health-York Cancer Center
  - York, Pennsylvania, United States, 17408
    - Recruiting
    - UPMC Memorial
- South Carolina
  - Bluffton, South Carolina, United States, 29910
    - Recruiting
    - Saint Joseph's/Candler - Bluffton Campus
  - Greenville, South Carolina, United States, 29601
    - Recruiting
    - Saint Francis Hospital
  - Greenville, South Carolina, United States, 29607
    - Recruiting
    - Saint Francis Cancer Center
  - Greenwood, South Carolina, United States, 29646
    - Active, not recruiting
    - Self Regional Healthcare
  - Greer, South Carolina, United States, 29651
    - Recruiting
    - Gibbs Cancer Center-Pelham
  - Spartanburg, South Carolina, United States, 29303
    - Recruiting
    - Spartanburg Medical Center
- South Dakota
  - Pierre, South Dakota, United States, 57501
    - Recruiting
    - Avera Cancer Institute at Pierre
    - Principal Investigator:
      
      Kyle Arneson
  - Sioux Falls, South Dakota, United States, 57104
    - Recruiting
    - Sanford Cancer Center Oncology Clinic
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Recruiting
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57105
    - Recruiting
    - Avera Cancer Institute
    - Principal Investigator:
      
      Kyle Arneson
  - Yankton, South Dakota, United States, 57078
    - Recruiting
    - Avera Cancer Institute at Yankton
    - Principal Investigator:
      
      Kyle Arneson
- Tennessee
  - Collierville, Tennessee, United States, 38017
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Collierville
  - Memphis, Tennessee, United States, 38120
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Memphis
- Texas
  - Conroe, Texas, United States, 77384
    - Recruiting
    - MD Anderson in The Woodlands
    - Principal Investigator:
      
      Matthew S. Ning
  - Houston, Texas, United States, 77030
    - Recruiting
    - M D Anderson Cancer Center
    - Principal Investigator:
      
      Matthew S. Ning
  - Houston, Texas, United States, 77030
    - Recruiting
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    - Principal Investigator:
      
      Pavan M. Jhaveri
  - Houston, Texas, United States, 77030
    - Recruiting
    - Ben Taub General Hospital
    - Principal Investigator:
      
      Pavan M. Jhaveri
  - Houston, Texas, United States, 77079
    - Recruiting
    - MD Anderson West Houston
    - Principal Investigator:
      
      Matthew S. Ning
  - Houston, Texas, United States, 77030
    - Recruiting
    - Michael E DeBakey VA Medical Center
    - Principal Investigator:
      
      Albert C. Chen
  - League City, Texas, United States, 77573
    - Recruiting
    - MD Anderson League City
    - Principal Investigator:
      
      Matthew S. Ning
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Audie L Murphy VA Hospital
    - Principal Investigator:
      
      Elizabeth V. Maani
  - Sugar Land, Texas, United States, 77478
    - Recruiting
    - MD Anderson in Sugar Land
    - Principal Investigator:
      
      Matthew S. Ning
- Utah
  - Farmington, Utah, United States, 84025
    - Recruiting
    - Farmington Health Center
  - Salt Lake City, Utah, United States, 84106
    - Recruiting
    - University of Utah Sugarhouse Health Center
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - Huntsman Cancer Institute/University of Utah
- Virginia
  - Fishersville, Virginia, United States, 22939
    - Recruiting
    - Augusta Health Center for Cancer and Blood Disorders
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - Virginia Commonwealth University/Massey Cancer Center
  - Richmond, Virginia, United States, 23235
    - Recruiting
    - VCU Massey Cancer Center at Stony Point
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Recruiting
    - Langlade Hospital and Cancer Center
  - Appleton, Wisconsin, United States, 54911
    - Recruiting
    - ThedaCare Regional Cancer Center
    - Principal Investigator:
      
      Shaneli A. Fernando
  - Ashland, Wisconsin, United States, 54806
    - Recruiting
    - Northwest Wisconsin Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - Recruiting
    - Marshfield Medical Center-EC Cancer Center
  - Green Bay, Wisconsin, United States, 54311
    - Recruiting
    - Aurora BayCare Medical Center
  - La Crosse, Wisconsin, United States, 54601
    - Recruiting
    - Gundersen Lutheran Medical Center
  - Ladysmith, Wisconsin, United States, 54848
    - Recruiting
    - Marshfield Clinic - Ladysmith Center
  - Marinette, Wisconsin, United States, 54143
    - Recruiting
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, United States, 54449
    - Recruiting
    - Marshfield Medical Center-Marshfield
  - Menomonee Falls, Wisconsin, United States, 53051
    - Recruiting
    - Froedtert Menomonee Falls Hospital
  - Milwaukee, Wisconsin, United States, 53215
    - Recruiting
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53233
    - Recruiting
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, United States, 53295
    - Recruiting
    - Zablocki Veterans Administration Medical Center
    - Contact:
      
      Site Public Contact
      
      Phone Number: 888-469-6614
    - Principal Investigator:
      
      Elizabeth M. Gore
  - Minocqua, Wisconsin, United States, 54548
    - Recruiting
    - Marshfield Clinic-Minocqua Center
  - Mukwonago, Wisconsin, United States, 53149
    - Recruiting
    - ProHealth D N Greenwald Center
  - Oak Creek, Wisconsin, United States, 53154
    - Recruiting
    - Drexel Town Square Health Center
  - Oconomowoc, Wisconsin, United States, 53066
    - Recruiting
    - ProHealth Oconomowoc Memorial Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Recruiting
    - Marshfield Medical Center-Rice Lake
  - Stevens Point, Wisconsin, United States, 54482
    - Recruiting
    - Marshfield Medical Center-River Region at Stevens Point
  - Waukesha, Wisconsin, United States, 53188
    - Recruiting
    - UW Cancer Center at ProHealth Care
  - Wausau, Wisconsin, United States, 54401
    - Recruiting
    - Aspirus Regional Cancer Center
  - West Allis, Wisconsin, United States, 53227
    - Recruiting
    - Aurora West Allis Medical Center
  - West Bend, Wisconsin, United States, 53095
    - Recruiting
    - Froedtert West Bend Hospital/Kraemer Cancer Center
  - Weston, Wisconsin, United States, 54476
    - Recruiting
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Recruiting
    - Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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) Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization	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) Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization	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 Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization	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 Time Frame: Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization	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 Time Frame: 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	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) Time Frame: Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720	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 Time Frame: 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)	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

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Chad G Rusthoven, SWOG Cancer Research Network

Study record dates

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

Study Major Dates

Study Start (Actual)

May 4, 2020

Primary Completion (Anticipated)

November 15, 2025

Study Completion (Anticipated)

November 15, 2027

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)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

Studies a U.S. FDA-regulated device product

Yes

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Extensive Stage Lung Small Cell Carcinoma

Clinical Trials on Magnetic Resonance Imaging

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations