Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
NCT ID: NCT01055197
Last Updated: 2018-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2010-03-31
2016-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCI
Prophylactic Cranial Irradiation (PCI)
Prophylactic Cranial Irradiation
Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.
PCI + Consolidation RT
Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Prophylactic Cranial Irradiation
Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.
Radiation Therapy
Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy
Interventions
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Prophylactic Cranial Irradiation
Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.
Radiation Therapy
Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Elizabeth M. Gore, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Alexander Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Center
Locations
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Arizona Oncology - Tucson
Tucson, Arizona, United States
Saint Agnes Cancer Center at Saint Agnes Medical Center
Fresno, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States
Baptist Medical Center South
Jacksonville, Florida, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States
Florida Cancer Center - Palatka
Palatka, Florida, United States
Flagler Cancer Center
Saint Augustine, Florida, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States
Emory Crawford Long Hospital
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Barnes-Jewish West County Hospital
St Louis, Missouri, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Trinity CancerCare Center
Minot, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
Southwest General Health Center
Middleburg Heights, Ohio, United States
UHHS Chagrin Highlands Medical Center
Orange, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Parma Community General Hospital
Parma, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
St. Anne Mercy Hospital
Toledo, Ohio, United States
UHHS Westlake Medical Center
Westlake, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Three Rivers Community Hospital
Grants Pass, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Texas Oncology, PA at Texas Cancer Center - Arlington South
Arlington, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Memorial Hermann Hospital - Memorial City
Houston, Texas, United States
Longview Cancer Center
Longview, Texas, United States
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology, PA - Wichita Falls
Wichita Falls, Texas, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, United States
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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CDR0000663959
Identifier Type: -
Identifier Source: secondary_id
NCI-2011-02008
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG 0937
Identifier Type: -
Identifier Source: org_study_id