Whole-Brain Radiation Therapy with or without Hippocampal Avoidance in Treating Patients with Limited Stage or Extensive Stage Small Cell Lung Cancer

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Status: Active

Description

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

Eligibility Criteria

Inclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION
  • Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration; * High-grade neuroendocrine carcinoma or combined SCLC and non-small cell lung cancer (NSCLC) is permitted
  • Patients must be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy, Note: * Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration * For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted
  • Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) magnetic resonance imaging (MRI) scan (axial T2/fluid attenuation inversion recovery (FLAIR) sequence); to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; sites may contact the Imaging Co-Chairs for further information or assistance if needed * This MRI must be obtained within 56 days prior to Step 1 registration. * Note: the MRI study is mandatory irrespective of randomization to the experimental or control arm of this study
  • Prior to chemotherapy +/- or thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following: * History/physical examination; * Computed tomography (CT) of the chest and abdomen with contrast (does not have to be done if the patient has had a positron emission tomography [PET]/CT scan prior to initiating chemotherapy or thoracic radiotherapy) * MRI of the brain with contrast or diagnostic head CT with contrast * For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC
  • After chemotherapy, patients must be restaged prior Step 1 registration using the same diagnostic work-up as required pre-chemotherapy; repeat PET/CT or bone scan is not required; patients must have: * History/physical examination within 30 days of Step 1 registration * No central nervous system (CNS) metastases (repeat MRI required) within 56 days prior to Step 1 registration * No progression in any site * Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration ** If PET/CT was obtained prior to chemotherapy, either a repeat PET/CT or CT of the chest and abdomen with contrast can be obtained for response assessment ** Patients who underwent resection for limited-stage SCLC prior to chemotherapy and have no radiographically evident disease for response assessment remain eligible if post-chemotherapy imaging demonstrates no progression
  • Zubrod performance status 0-2 within 30 days prior to Step 1 registration
  • Women of childbearing potential must have a negative qualitative serum pregnancy test =< 14 days prior to Step 1 registration
  • Patients who are primary English or French speakers are eligible
  • Patients must sign a study-specific informed consent prior to study entry
  • PRIOR TO STEP 2 REGISTRATION
  • The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after or at the time of Step 1 registration: HVLT-R (recall, delayed recall, and recognition), TMT (parts A and B), and COWA; the neurocognitive assessments will be uploaded into the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE system for evaluation by Dr. Wefel; once the upload is complete, within 3 business days, a notification will be sent to the site to proceed to Step 2 registration; at minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible
  • Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall. as determined by central assessment by the Neurocognitive Co-Chair, Dr. Wefel

Exclusion Criteria

  • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
  • Radiographic evidence of CNS metastases
  • Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
  • Planned concurrent chemotherapy during PCI * Concurrent atezolizumab permitted
  • Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted
  • Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
  • Severe, active comorbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Uncontrolled, clinically significant cardiac arrhythmias * Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter ** Note: 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 30 days prior to Step 1 registration ** Note: HIV testing is not required for eligibility for this protocol
  • Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.

Locations & Contacts

Alabama

Tuscaloosa
Lewis and Faye Manderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-338-2948

Arizona

Tucson
Banner University Medical Center - Tucson
Status: Active
Contact: Site Public Contact
Email: aselegue@email.arizona.edu

California

Greenbrae
Marin General Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-925-7325
Los Angeles
Los Angeles County-USC Medical Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Oakland
Kaiser Permanente Oakland-Broadway
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Saint Joseph Hospital - Orange
Status: Active
Contact: Site Public Contact
Phone: 714-734-6220
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
The Permanente Medical Group-Roseville Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
California Pacific Medical Center-Pacific Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 530-582-6450
Vallejo
Sutter Solano Medical Center / Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org

Colorado

Englewood
Swedish Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Connecticut

Bridgeport
Saint Vincent's Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
New Haven
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Boca Raton
Boca Raton Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 561-955-4800
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Fort Lauderdale
Broward Health Medical Center
Status: Active
Contact: Site Public Contact
Phone: 954-355-5346
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com
Tampa
Moffitt Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: Active
Contact: Site Public Contact
Phone: 888-946-7447
Grady Health System
Status: Active
Contact: Site Public Contact
Phone: 404-489-9164
Northside Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-303-3355
Email: ClinicalTrials@northside.com
Cumming
Northside Hospital-Forsyth
Status: Active
Contact: Site Public Contact
Phone: 404-303-3355
Email: clinicaltrials@northside.com
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org
Memorial Health University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Hawaii

Aiea
The Cancer Center of Hawaii-Pali Momi
Status: Active
Contact: Site Public Contact
Phone: 808-678-9000
Honolulu
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-545-8548
The Cancer Center of Hawaii-Liliha
Status: Active
Contact: Site Public Contact
Phone: 808-547-6881

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Site Public Contact
Phone: 312-864-5204
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Rush University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Geneva
Northwestern Medicine Cancer Center Delnor
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Hines
Edward Hines Jr VA Hospital
Status: Active
Contact: Site Public Contact
Phone: 708-202-8387
Libertyville
Condell Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 630-929-6129
Email: advocateresearch@advocatehealth.com
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Peoria
Methodist Medical Center of Illinois
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-788-3528
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

Indiana

Fort Wayne
Parkview Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-784-4673

Iowa

Des Moines
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Lawrence
Lawrence Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Wichita
Ascension Via Christi Hospitals Wichita
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org
Wesley Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

New Orleans
Tulane University Health Sciences Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 504-988-6121

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
MedStar Franklin Square Medical Center / Weinberg Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 443-777-7364
MedStar Good Samaritan Hospital
Status: Active
Contact: Site Public Contact
Phone: 410-261-8151
Email: Barbara.rector@medstar.net
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-888-8823
University of Maryland Medical Center
Status: Approved
Contact: Minesh P. Mehta
Phone: 410-328-6921
Email: mmehta@umm.edu
Bel Air
UM Upper Chesapeake Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-643-3010
Columbia
Central Maryland Radiation Oncology in Howard County
Status: Active
Contact: Site Public Contact
Phone: 443-546-1300
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-553-8100
Ocean Pines
Richard A Henson Cancer Institute at Ocean Pines
Status: Active
Contact: Site Public Contact
Phone: 410-543-7017
Email: stephanie.cason@peninsula.org
Salisbury
Peninsula Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 866-922-6237
Towson
UM Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 410-337-4569
Email: patriciajohnson@catholichealth.net

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 781-744-3421
Email: cancerclinicaltrials@lahey.org
Lowell
Lowell General Hospital
Status: Active
Contact: Site Public Contact
Phone: 978-788-7084
Email: ghincks@lowellgeneral.org
Worcester
UMass Memorial Medical Center - University Campus
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bay City
McLaren Cancer Institute-Bay City
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Clarkston
21st Century Oncology MHP - Clarkston
Status: Active
Contact: Site Public Contact
Phone: 248-338-0663
McLaren Cancer Institute-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Farmington Hills
21st Century Oncology MHP - Farmington
Status: Active
Contact: Site Public Contact
Phone: 248-338-0663
Flint
Genesys Hurley Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
McLaren Cancer Institute-Flint
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Grand Rapids
Mercy Health Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Livonia
Saint Mary Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Mount Clemens
McLaren Cancer Institute-Macomb
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Muskegon
Mercy Health Mercy Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Owosso
McLaren Cancer Institute-Owosso
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Pontiac
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Port Huron
McLaren-Port Huron
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Troy
21st Century Oncology MHP - Troy
Status: Active
Contact: Site Public Contact
Phone: 248-338-0663
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

Duluth
Saint Luke's Hospital of Duluth
Status: Active
Contact: Site Public Contact
Phone: 218-249-7825
Email: kdean@slhduluth.com
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Joplin
Freeman Health System
Status: Active
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Kansas City
North Kansas City Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 816-691-1599
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Siteman Cancer Center-South County
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Montana

Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Nevada

Reno
Renown Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Hampshire

Dover
Wentworth-Douglass Hospital
Status: Active
Contact: Site Public Contact
Phone: 603-740-2150
Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Englewood
Englewood Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-894-3456
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 718-780-3677
Email: Adg9003@nyp.org
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 607-271-7000
Lake Success
Northwell Health / Center for Advanced Medicine
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
New York
Lenox Hill Hospital
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Staten Island
Staten Island University Hospital
Status: Active
Contact: Site Public Contact
Phone: 718-226-8888
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592

North Carolina

Charlotte
Atrium Health Pineville / LCI-Pineville
Status: Active
Contact: Site Public Contact
Phone: 980-442-2000
Atrium Health University City / LCI-University
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Concord
Atrium Health Cabarrus / LCI-Concord
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Monroe
Atrium Health Union / LCI-Union
Status: Active
Contact: Site Public Contact
Phone: 980-442-2000
Shelby
Atrium Health Cleveland / LCI-Cleveland
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Summa Health System - Akron Campus
Status: Active
Contact: Site Public Contact
Phone: 330-375-4221
Email: cancerresearch@summahealth.org
Chardon
Geauga Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Chillicothe
Adena Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Columbus
Mount Carmel Health Center West
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Elyria
Mercy Cancer Center-Elyria
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Independence
Cleveland Clinic Cancer Center Independence
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Parma
University Hospitals Parma Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Westlake
UHHS-Westlake Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org

Pennsylvania

Broomall
Crozer-Keystone Regional Cancer Center at Broomall
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 610-284-8237
Email: Jolene.garney@crozer.org
Bryn Mawr
Bryn Mawr Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Chadds Ford
Christiana Care Health System-Concord Health Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Dunmore
Northeast Radiation Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 888-808-6762
Gettysburg
Adams Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957
Glen Mills
Crozer Regional Cancer Center at Brinton Lake
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 610-284-8237
Media
Riddle Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Philadelphia
Aria Health-Torresdale Campus
Status: Active
Contact: Site Public Contact
Phone: 215-612-5296
Fox Chase Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 215-728-4790
Temple University Hospital
Status: Active
Contact: Site Public Contact
Phone: 215-728-2983
Thomas Jefferson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 215-955-6084
Reading
Penn State Health Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 610-378-2336
Email: dward1@pennstatehealth.psu.edu
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
York
WellSpan Health-York Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957

South Carolina

Anderson
AnMed Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-512-4651
Email: rhonda.ballew@anmedhealth.org
Greenville
Prisma Health Cancer Institute - Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Faris
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Greenwood
Self Regional Healthcare
Status: Active
Contact: Site Public Contact
Phone: 864-725-4771
Email: nmcgaha@selfregional.org
Hilton Head Island
The Radiation Oncology Center-Hilton Head / Bluffton
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org
Lancaster
Lancaster Radiation Therapy Center
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Rock Hill
Rock Hill Radiation Therapy Center
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Knoxville
Thompson Cancer Survival Center
Status: Active
Contact: Site Public Contact
Phone: 865-331-1812
Maryville
Blount Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 865-331-1812
Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Galveston
University of Texas Medical Branch
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 409-772-1950
Email: clinical.research@utmb.edu
League City
UTMB Cancer Center at Victory Lakes
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-917-8906

Utah

Ogden
Ogden Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: Active
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont Medical Center
Status: Active
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu
Saint Johnsbury
Norris Cotton Cancer Center-North
Status: Active
Contact: Site Public Contact
Phone: 802-473-4100

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Email: Juli.Alford@aspirus.org
Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Status: Active
Contact: Site Public Contact
Phone: 414-635-6420
Email: AWRI.Inquiry@Ascension.org
Franklin
Ascension Saint Francis - Reiman Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 414-635-6420
Email: AWRI.Inquiry@Ascension.org
Johnson Creek
UW Cancer Center Johnson Creek
Status: Active
Contact: Site Public Contact
Phone: 920-699-3500
Email: lynda.persico@uwmf.wisc.edu
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Menomonee Falls
Community Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 262-257-5100
Milwaukee
Medical College of Wisconsin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 414-805-3666
Racine
Ascension All Saints Hospital
Status: Active
Contact: Site Public Contact
Phone: 414-635-6420
Email: AWRI.Inquiry@Ascension.org
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Aspirus Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
Weston
Diagnostic and Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 888-799-3989
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Aspirus UW Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-422-7718

Ontario

London
London Regional Cancer Program
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 519-685-8600
Newmarket
Stronach Regional Health Centre at Southlake
Status: Active
Contact: Site Public Contact
Phone: 905-895-4521ext6820
Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: Active
Contact: Site Public Contact
Phone: 613-761-4395
Toronto
University Health Network-Princess Margaret Hospital
Status: Active
Contact: Site Public Contact
Phone: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-890-8000ext12725
Email: info.cr.chum@ssss.gouv.qc.ca
CHUM - Hopital Notre-Dame
Status: Temporarily closed to accrual
Contact: Anne Dagnault
Phone: 418-649-5593
Email: jbegin@uresp.ulaval.ca
McGill University Department of Oncology
Status: Active
Contact: Anne Dagnault
Email: rechclinique@crchuq.ulaval.ca
The Research Institute of the McGill University Health Centre (MUHC)
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-934-1934ext48354
Email: evelyn.ortega@muhc.mcgill.ca
Quebec City
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Status: Active
Contact: Site Public Contact
Email: rechclinique@crchuq.ulaval.ca
Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 819-820-6480
Email: crcinformation.chus@ssss.gouv.qc.ca

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 306-766-2213
Saskatoon
Saskatoon Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 306-655-2914

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Determine whether the 12-month intracranial relapse rate following hippocampal avoidance (HA)-prophylactic cranial irradiation (PCI) is non-inferior to the rate following PCI for patients with small cell lung cancer (SCLC). (Randomized Phase II Component [Non-Inferiority])

II. Determine whether HA-PCI reduces the likelihood of 6-month deterioration from baseline in Hopkins Verbal Learning Test (HVLT)-Revised (R) delayed recall compared to PCI for patients with SCLC. (Phase III Component [Efficacy])

SECONDARY OBJECTIVES:

I. Compare time to cognitive failure, as measured by a battery of tests (HVLT-R, Controlled Oral Word Association [COWA] test, and Trail Making Test [TMT] parts A and B), after PCI versus HA-PCI in SCLC.

II. Compare time to cognitive failure as separately measured by each test (HVLT-R for Total Recall and Delayed Recognition, COWA test, and TMT parts A and B), after PCI versus HA-PCI for SCLC.

III. Compare patient-reported cognitive functioning and other quality of life domains (assessed by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-Core [C]30 and BN20) between PCI versus HA-PCI for patients with SCLC.

IV. Compare overall survival after PCI versus HA-PCI for patients with SCLC.

V. Compare 12-month intracranial relapse rate (at completion of phase III) and time to intracranial relapse after PCI versus HA-PCI for patients with SCLC.

VI. Evaluate adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria.

VII. Correlate changes in health-related quality of life (HRQOL) domains with changes in cognitive testing outcomes following PCI versus HA-PCI for patients with SCLC.

VIII. Assess cost-effectiveness of HA-PCI (modulated radiation therapy [MRT]) and PCI (3-dimensional conformal radiation therapy [3DCRT]) using the EuroQOL-5 dimension (D) health state classification (EQ-5D-5L).

IX. Correlate micro-ribonucleic acid (miRNA) signatures with cognitive failure in SCLC patients who received PCI and HA-PCI.

EXPLORATORY OBJECTIVES:

I. Collect serum and whole blood for future translational research analyses.

II. Evaluate baseline magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HAPCI as compared to PCI.

III. Compare levels of hopefulness between PCI versus HA-PCI for patients with SCLC.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo PCI using 3DCRT daily for 2 weeks.

ARM II: Patients undergo PCI with HA using IMRT daily for 2 weeks.

After completion of study treatment, patients are followed every 3 months for 1 year, then every 6 months until 3 years and then annually until death.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Vinai Gondi

Trial IDs

Primary ID NRG-CC003
Secondary IDs NCI-2015-01548
Clinicaltrials.gov ID NCT02635009