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Clinical Trials (PDQ®)

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCI, OtherRTOG 0937
CDR0000663959, NCI-2011-02008, NCT01055197

Trial Description

Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.

PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.

Further Study Information

OBJECTIVES:

Primary

  • To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy.

Secondary

  • To compare treatment-related adverse events in these patients.
  • To evaluate patterns of failure in these patients.
  • To compare the time to first failure in these patients.
  • To evaluate the percentage of the planned radiotherapy dose given to each site.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.
  • Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks.

After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) diagnosed within the past 6 months*
  • Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment with chemotherapy
  • Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND meets the following criteria:
  • Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (if radiotherapy has been delivered to primary disease with chemotherapy, there must be complete or partial response in ≥ 1 of the sites that has not been treated with radiotherapy)
  • No progression in any site
  • No limited stage SCLC, even if disease progressed
  • No brain or central nervous system (CNS) metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3
  • Platelets ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver)
  • Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the liver)
  • Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the kidneys)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No severe, active co-morbidity, defined as any of the following:
  • Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study registration

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy and alopecia])
  • Thoracic radiotherapy administered concurrently with or before chemotherapy for the current diagnosis allowed (these patients will not receive mediastinal radiotherapy per protocol)
  • No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
  • No concurrent chemotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

NRG Oncology

Elizabeth M. GorePrincipal Investigator

Alexander Sun, MDPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Tucson
 Arizona Oncology - Tucson
 Vivek S Kavadi Ph: 281-277-5200
California
  Sacramento
 Sutter Cancer Center
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Brian D Kavanagh Ph: 720-848-0650
  Colorado Springs
 Memorial Hospital Cancer Center - Colorado Springs
 Stephen H Thatcher Ph: 719-365-2406
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Neal B Goldberg Ph: 860-224-5660
Florida
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Mark E Augspurger Ph: 904-202-7051
  Jascksonville
 Integrated Community Oncology Network - Baptist South
 Mark E Augspurger Ph: 904-202-7051
  Orange Park
 Integrated Community Oncology Network - Orange Park
 Mark E Augspurger Ph: 904-202-7051
  Palatka
 Cancer Specialists of North Florida-Putnam
 Mark E Augspurger Ph: 904-202-7051
  Saint Augustine
 Integrated Community Oncology Network at St. Augustine Cancer Center
 Mark E Augspurger Ph: 904-202-7051
Georgia
  Atlanta
 Georgia Cancer Center for Excellence at Grady Memorial Hospital
 Kristin A Higgins Ph: 404-778-1868
 Winship Cancer Institute of Emory University
 Kristin A Higgins Ph: 404-778-1868
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 John A Pablo Ph: 800-622-6877
Hawaii
  Honolulu
 Hawaii Medical Center - East
 Paul A. DeMare Ph: 808-545-8548
 Queen's Cancer Institute at Queen's Medical Center
 Paul A. DeMare Ph: 808-545-8548
Illinois
  Chicago
 John H. Stroger, Jr. Hospital of Cook County
 Jagdish V Thakrar Ph: 312-864-6000
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 MaryAnne H Marymont Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Sulochana D Yalavarthi Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  Springfield
 Cancer Institute at St. John's Hospital
 Cathy L. Clausen Ph: 217-525-5666
  Email: diana.weyhenmeyer@st-johns.org
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Kalika P. Sarma Ph: 800-446-5532
Indiana
  Anderson
 Saint John's Health System
 Alexander M. Yeh Ph: 765-646-8358
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
 Radiation Oncology Associates Southwest
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
  Indianapolis
 Community Regional Cancer Care at Community Hospital East
 Shih J Wei Ph: 317-621-7104
 Community Regional Cancer Care at Community Hospital North
 Shih J Wei Ph: 317-621-7104
  Muncie
 Cancer Center at Ball Memorial Hospital
 Yunjie X Lin Ph: 765-751-5850
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Ronald McGarry Ph: 859-257-3379
  Louisville
 University of Louisville School of Medicine
 Neal E Dunlap Ph: 866-530-5516
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Mini J Elnaggar Ph: 888-562-4763
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Robert K. Brookland Ph: 443-849-3706
 St. Agnes Hospital Cancer Center
 Richard S. Hudes Ph: 410-368-2910
  Salisbury
 Peninsula Regional Medical Center
 Matthew L Snyder Ph: 866-922-6237
Michigan
  Clinton Township
 Henry Ford Macomb Hospital
 Eleanor M. Walker Ph: 313-916-1784
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Eleanor M. Walker Ph: 313-916-1784
  Flint
 McLaren Cancer Institute
 Hesham E. Gayar Ph: 810-342-4071
  Grand Rapids
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lapeer
 Great Lakes Cancer Institute - Lapeer Campus
 Hesham E. Gayar Ph: 810-342-4071
  Owosso
 Great Lakes Cancer Institute - Owosso
 Hesham E. Gayar Ph: 810-342-4071
Minnesota
  Duluth
 St. Luke's Hospital Cancer Care Center
 Steven R Bonin Ph: 888-823-5923
  Email: ctsucontact@westat.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Shankar P Giri Ph: 601-815-6700
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Saint Louis
 Barnes-Jewish West County Hospital
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Saint Louis University Cancer Center
 Bruce J. Walz Ph: 314-977-4440
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
New Hampshire
  Manchester
 Elliot Regional Cancer Center at Elliot Hospital
 Brian R Knab Ph: 603-663-1800
New Jersey
  Basking Ridge
 Memorial Sloan-Kettering Cancer Center - Basking Ridge
 Abraham J Wu Ph: 212-639-7202
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Tamara A LaCouture Ph: 856-325-6757
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Maria Werner-Wasik Ph: 215-955-6084
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Tamara A LaCouture Ph: 856-325-6757
New York
  Brooklyn
 Maimonides Cancer Center at Maimonides Medical Center
 James B. Butler Ph: 866-561-1026
  Email: CIO_Web@cancercare.mb.ca
 New York Methodist Hospital
 Sameer Rafla-Demetrious Ph: 718-780-5240
  Canandiaqua
 Sands Cancer Center
 Yuhchyau Chen Ph: 585-275-5830
  Commack
 Memorial Sloan-Kettering Cancer Center
 Abraham J Wu Ph: 212-639-7202
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Simon K Cheng Ph: 212-305-8615
 Memorial Sloan-Kettering Cancer Center
 Abraham J Wu Ph: 212-639-7202
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
 University Radiation Oncology at Parkridge Hospital
 Yuhchyau Chen Ph: 585-275-5830
  Rockville Centre
 Memorial Sloan-Kettering Cancer Center - Rockville Centre
 Abraham J Wu Ph: 212-639-7202
  Sleepy Hollow
 Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
 Abraham J Wu Ph: 212-639-7202
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Elizabeth M. Gore Ph: 414-805-4465
  Email: egore@mcw.edu
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
  Supply
 South Atlantic Radiation Oncology, LLC
 Michael A Papagikos Ph: 910-251-1839
  Wilmington
 Coastal Carolina Radiation Oncology Center
 Michael A Papagikos Ph: 910-251-1839
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Brian E Lally Ph: 336-713-6771
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Lee Fromm Ph: 330-344-6348
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  Chardon
 Geauga Regional Hospital
 Mitchell Machtay Ph: 800-641-2422
  Cincinnati
 Oncology Hematology Care, Incorporated - Blue Ash
 Howard M. Gross Ph: 937-775-1350
  Cleveland
 Case Comprehensive Cancer Center
 Mitchell Machtay Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Mitchell Machtay Ph: 800-641-2422
 Cleveland Clinic Taussig Cancer Center
 Mitchell Machtay Ph: 800-641-2422
  Independence
 Cleveland Clinic Taussig Cancer Center
 Mitchell Machtay Ph: 800-641-2422
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Mitchell Machtay Ph: 800-641-2422
  Medina
 Summa Health Center at Lake Medina
 Charles A Kunos Ph: 330-375-6101
  Mentor
 Lake/University Ireland Cancer Center
 Mitchell Machtay Ph: 800-641-2422
  Middleburg Heights
 Southwest General Health Center
 Mitchell Machtay Ph: 800-641-2422
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Mitchell Machtay Ph: 800-641-2422
  Parma
 Parma Community General Hospital
 Mitchell Machtay Ph: 800-641-2422
  Ravenna
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
  Sandusky
 North Coast Cancer Care, Incorporated
 Gregory Videtic Ph: 866-223-8100
  Strongsville
 Cleveland Clinic Foundation - Strongsville
 Gregory Videtic Ph: 866-223-8100
  Westlake
 UHHS Westlake Medical Center
 Mitchell Machtay Ph: 800-641-2422
  Wooster
 Cleveland Clinic - Wooster
 Mitchell Machtay Ph: 800-641-2422
Oregon
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Andrew Y Kee Ph: 507-538-7623
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
  Dunmore
 Northeast Radiation Oncology Center
 Maria Werner-Wasik Ph: 215-955-6084
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Aruna Turaka Ph: 215-728-4790
 Frankford Hospital Cancer Center - Torresdale Campus
 Maria Werner-Wasik Ph: 215-955-6084
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Maria Werner-Wasik Ph: 215-955-6084
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Thomas J Gergel Ph: 570-271-5251
South Carolina
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
  Hilton Head Island
 Hilton Head Radiation Oncology Center
 John A Pablo Ph: 800-622-6877
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Patricia C Griffin Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
  Email: research@rcrh.org
Texas
  Arlington
 Texas Oncology, PA at Texas Cancer Center - Arlington South
 Stephen D Sorgen Ph: 281-277-5200
  Austin
 Texas Oncology - Midtown Austin
 Vivek S Kavadi Ph: 281-277-5200
 Texas Oncology, PA at South Austin Cancer Center
 Vivek S Kavadi Ph: 281-277-5200
 Texas Oncology, PA at Texas Oncology Cancer Center - Central
 Vivek S Kavadi Ph: 281-277-5200
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Hak Choy Ph: 214-648-7097
  Denton
 Texas Oncology, PA at Texas Cancer Center - Denton South
 Vivek S Kavadi Ph: 281-277-5200
  Fort Worth
 Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
 Vivek S Kavadi Ph: 281-277-5200
  Galveston
 University of Texas Medical Branch
 Todd A Swanson Ph: 409-772-1950
  Email: clinical.research@utmb.edu
  Houston
 Memorial Hermann Hospital - Memorial City
 Vivek S Kavadi Ph: 281-277-5200
  League City
 UTMB Cancer Center at Victory Lakes
 Todd A Swanson Ph: 409-772-1950
  Email: clinical.research@utmb.edu
  Longview
 Longview Cancer Center
 Vivek S Kavadi Ph: 281-277-5200
  Round Rock
 Texas Oncology, PA - Seton Williamson
 Vivek S Kavadi Ph: 281-277-5200
 Texas Oncology, PA at Texas Cancer Center Round Rock
 Vivek S Kavadi Ph: 281-277-5200
  Sherman
 Texas Oncology, PA at Texas Cancer Center - Sherman
 Vivek S Kavadi Ph: 281-277-5200
  Sugar Land
 Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
 Stephen D Sorgen Ph: 281-277-5200
  Tyler
 Tyler Cancer Center
 Vivek S Kavadi Ph: 281-277-5200
Wisconsin
  Johnson Creek
 UW Cancer Center Johnson Creek
 Steven P Howard Ph: 877-405-6866
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Steven P Howard Ph: 877-405-6866
  Menomonee Falls
 Community Memorial Hospital Cancer Care Center
 Elizabeth M. Gore Ph: 414-805-4380
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Elizabeth M. Gore Ph: 414-805-4380
 Veterans Affairs Medical Center - Milwaukee
 Elizabeth M. Gore Ph: 414-805-4380
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Wingate F. Clapper Ph: 262-928-7632
  Racine
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 James H. Taylor Ph: 414-874-4541
  Email: Kelli.holton@wfhc.org
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Wingate F. Clapper Ph: 262-928-7632
  West Bend
 Alyce and Elmore Kraemer Cancer Care Center at St. Joseph's Hospital
 Elizabeth M. Gore Ph: 414-805-4380
  Wisconsin Rapids
 Riverview UW Cancer Center at Riverview Hospital
 Steven P Howard Ph: 877-405-6866
Canada
Alberta
  Edmonton
 Cross Cancer Institute at University of Alberta
 Don Yee Ph: 780-432-8500
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Anand Swaminath Ph: 905-387-9495
  Toronto
 Princess Margaret Hospital
 Alexander Y Sun Ph: 416-946-4501
  Email: clinical.trials@uhn.on.ca
Quebec
  Montreal
 McGill Cancer Centre at McGill University
 Elizabeth M. Gore Ph: 414-805-4465
  Email: egore@mcw.edu
Saskatchewan
  Regina
 Allan Blair Cancer Centre at Pasqua Hospital
 Arbind Dubey Ph: 306-766-2213
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Vijayananda Kundapur Ph: 306-655-2914
Israel
  Tel Aviv
 Tel-Aviv Sourasky Medical Center
 Ofer Merimsky Ph: 011-972-3-6974761
  Email: mop@tasmc.health.gov.il
Republic of Singapore
  Singapore
 Cancer Institute at National University Hospital
 Ivan W Tham Ph: 215-574-3173

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01055197
ClinicalTrials.gov processed this data on November 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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