Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Radiation: Prophylactic Cranial IrradiationRadiation: Radiation Therapy
- Registration Number
- NCT01055197
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCI Prophylactic Cranial Irradiation Prophylactic Cranial Irradiation (PCI) PCI + Consolidation RT Prophylactic Cranial Irradiation Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease PCI + Consolidation RT Radiation Therapy Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
- Primary Outcome Measures
Name Time Method Overall Survival (12-month Rate Reported) From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months. The 12-month rate is reported.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months. Adverse events (AE) are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Patterns of Failure - Number of Patients With Failure by Site From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months. Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging \[per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\] and physical examination. A patient could be counted in more than one category.
First Failure (12-month Rate Reported) From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months. Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging \[per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\] and physical examination. Time to first failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death (competing risk). First failure rates are estimated using the cumulative incidence method.
Percentage of Planned Radiotherapy Dose (All Sites) That Was Delivered From start to end of radiation therapy; up to 32 days for Prophylactic Cranial Irradiation arm, up to 68 days for Prophylactic Cranial Irradiation + Consolidation Radiotherapy arm. Total dose to the brain was to be 25 Gy for all patients. For patients on PCI+consolidative RT, patients were to get 45 Gy at 3 Gy per fraction to the locoregional area as well as to residual metastatic disease. Alternatively, these regions could have received 30-40 Gy in 10 fractions. The total planned dose was determined, and a percentage was calculated based for each patient as total delivered dose / total planned dose.
Trial Locations
- Locations (115)
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Integrated Community Oncology Network at Southside Cancer Center
🇺🇸Jacksonville, Florida, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Saint Agnes Cancer Center at Saint Agnes Medical Center
🇺🇸Fresno, California, United States
Integrated Community Oncology Network - Orange Park
🇺🇸Orange Park, Florida, United States
Integrated Community Oncology Network
🇺🇸Jacksonville Beach, Florida, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Poudre Valley Radiation Oncology
🇺🇸Fort Collins, Colorado, United States
Flagler Cancer Center
🇺🇸Saint Augustine, Florida, United States
Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Memorial Hermann Hospital - Memorial City
🇺🇸Houston, Texas, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Baptist Medical Center South
🇺🇸Jacksonville, Florida, United States
Florida Cancer Center - Palatka
🇺🇸Palatka, Florida, 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
St. Agnes Hospital Cancer Center
🇺🇸Baltimore, Maryland, 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
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Barnes-Jewish West County Hospital
🇺🇸Saint Louis, Missouri, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, 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
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
NYU Cancer Institute at New York 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
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
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
Lake/University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
UHHS Chagrin Highlands Medical Center
🇺🇸Orange Village, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Parma Community General Hospital
🇺🇸Parma, 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
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
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
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
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Rabin Medical Center - Beilinson Campus
🇮🇱Petach Tikva, Israel
Frederick R. and Betty M. Smith Cancer Treatment Center
🇺🇸Sparta, New Jersey, United States
Renown Institute for Cancer at Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Arizona Oncology - Tucson
🇺🇸Tucson, Arizona, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Elliot Regional Cancer Center at Elliot Hospital
🇺🇸Manchester, New Hampshire, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Northeastern Ontario Regional Cancer Centre
🇨🇦Sudbury, Ontario, Canada
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸Sacramento, California, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸Orlando, Florida, 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
Kansas City Cancer Centers - South
🇺🇸Kansas City, Missouri, United States
Kansas City Cancer Centers - North
🇺🇸Kansas City, Missouri, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
🇺🇸Milwaukee, Wisconsin, 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
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Southwest General Health Center
🇺🇸Middleburg Heights, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States