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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01055197
First received: January 22, 2010
Last updated: May 1, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: prophylactic cranial irradiation
Radiation: selective external radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of treatment-related adverse events [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
  • Patterns of failure [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ] [ Designated as safety issue: No ]
  • Comparison of time to first failure [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ] [ Designated as safety issue: No ]
  • Evaluation of the percentage of the planned radiotherapy dose to each site [ Time Frame: From start to end of radiation therapy. ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: March 2010
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.
Radiation: prophylactic cranial irradiation
Given 5 days per week for 2 weeks
Experimental: 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.
Radiation: prophylactic cranial irradiation
Given 5 days per week for 2 weeks
Radiation: selective external radiation therapy
Given 5 days per week for 2-3 weeks

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055197

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
United States, California
Saint Agnes Cancer Center at Saint Agnes Medical Center
Fresno, California, United States, 93720
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
United States, Colorado
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States, 32250
Baptist Medical Center South
Jascksonville, Florida, United States, 32258
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States, 32073
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Florida Cancer Center - Palatka
Palatka, Florida, United States, 32177
Flagler Cancer Center
Saint Augustine, Florida, United States, 32086
United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Indiana
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States, 46804
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States, 46256
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Henry Ford Macomb Hospital
Clinton Township, Michigan, United States, 48038
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States, 12206
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, North Dakota
Trinity CancerCare Center
Minot, North Dakota, United States, 58701
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
UHHS Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Parma Community General Hospital
Parma, Ohio, United States, 44129
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
UHHS Westlake Medical Center
Westlake, Ohio, United States, 44145
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
United States, Pennsylvania
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, South Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Texas Oncology, PA at Texas Cancer Center - Arlington South
Arlington, Texas, United States, 76014
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, United States, 76210
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
Memorial Hermann Hospital - Memorial City
Houston, Texas, United States, 77024
Longview Cancer Center
Longview, Texas, United States, 75601
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, United States, 78217
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Oncology, PA - Wichita Falls
Wichita Falls, Texas, United States, 76310
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Israel
Rabin Medical Center - Beilinson Campus
Petach Tikva, Israel, 49100
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology
Investigators
Principal Investigator: Elizabeth M. Gore, MD Medical College of Wisconsin
Principal Investigator: Alexander Sun, MD Princess Margaret Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01055197     History of Changes
Other Study ID Numbers: RTOG 0937, CDR0000663959, NCI-2011-02008
Study First Received: January 22, 2010
Last Updated: May 1, 2015
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on July 01, 2015