A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
Sponsored by Alliance for Clinical Trials in Oncology
About this study
This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.
PRIMARY OBJECTIVES: I. To assess whether intensity-modulated post-operative radiation therapy (I²-PORT) improves disease-free survival (DFS) of patients with R0 resected ypN2 NSCLC compared to standard of care (SOC). II. To assess whether I²-PORT does not unacceptably increase (by ≥ 6.5 percentage points) the rate of severe (grade ≥ 3 per Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5) late cardiopulmonary toxicity compared to SOC. SECONDARY OBJECTIVES: I. 5-year DFS, 2- and 5-year overall survival (OS). II. Local versus (vs.) regional control, rate of distant metastases. III. Acute and late adverse events (AE) rates of specific cardiac, pulmonary, and other toxicities, per CTCAE version 5.0. IV. Rates of non-mild, moderate, or severe-very severe symptoms per…
Where this study is enrolling (97)
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas
- Call 323-865-0451
USC / Norris Comprehensive Cancer Center
Los Angeles, California
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Rush MD Anderson Cancer Center
Chicago, Illinois
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OSF Saint Joseph Medical Center
Bloomington, Illinois
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OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois
Show all 97 locations
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OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois
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OSF Saint Francis Medical Center
Peoria, Illinois
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Decatur Memorial Hospital
Decatur, Illinois
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Illinois CancerCare-Princeton
Princeton, Illinois
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Illinois CancerCare-Peru
Peru, Illinois
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Illinois CancerCare-Peoria
Peoria, Illinois
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Cancer Care Center of O'Fallon
O'Fallon, Illinois
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Illinois CancerCare-Pekin
Pekin, Illinois
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois
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Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois
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Illinois CancerCare-Macomb
Macomb, Illinois
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois
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Illinois CancerCare-Galesburg
Galesburg, Illinois
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HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois
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Illinois CancerCare - Washington
Washington, Illinois
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Illinois CancerCare-Bloomington
Bloomington, Illinois
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Illinois CancerCare-Carthage
Carthage, Illinois
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Illinois CancerCare-Canton
Canton, Illinois
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Illinois CancerCare-Eureka
Eureka, Illinois
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MaineHealth Maine Medical Center - Portland
Portland, Maine
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MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine
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MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine
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MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine
- Call 207-459-1600
MaineHealth Cancer Care Center of York County
Sanford, Maine
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MaineHealth Coastal Cancer Treatment Center
Bath, Maine
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan
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Trinity Health Medical Center - Brighton
Brighton, Michigan
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan
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Chelsea Hospital
Chelsea, Michigan
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Trinity Health Medical Center - Canton
Canton, Michigan
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Miller-Dwan Hospital
Duluth, Minnesota
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Essentia Health Cancer Center
Duluth, Minnesota
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Essentia Health - Deer River Clinic
Deer River, Minnesota
- Call 218-786-3308
Essentia Health Hibbing Clinic
Hibbing, Minnesota
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Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota
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Essentia Health Saint Mary's Medical Center
Duluth, Minnesota
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Essentia Health Sandstone
Sandstone, Minnesota
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Essentia Health Virginia Clinic
Virginia, Minnesota
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Sanford Joe Lueken Cancer Center
Bemidji, Minnesota
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Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi
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Saint Francis Medical Center
Cape Girardeau, Missouri
- Call 212-639-7592
Memorial Sloan Kettering Monmouth
Middletown, New Jersey
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Memorial Sloan Kettering Bergen
Montvale, New Jersey
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
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Memorial Sloan Kettering Commack
Commack, New York
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Memorial Sloan Kettering Cancer Center
New York, New York
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Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York
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Montefiore Medical Center-Einstein Campus
The Bronx, New York
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Memorial Sloan Kettering Nassau
Uniondale, New York
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New York Proton Center
New York, New York
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Memorial Sloan Kettering Westchester
Harrison, New York
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Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York
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Upstate Cancer Center at Verona
Verona, New York
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Upstate Cancer Center at Oswego
Oswego, New York
- Call 315-464-5476
State University of New York Upstate Medical University
Syracuse, New York
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Montefiore Medical Center - Moses Campus
The Bronx, New York
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
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Sanford Bismarck Medical Center
Bismarck, North Dakota
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Sanford Broadway Medical Center
Fargo, North Dakota
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Sanford Roger Maris Cancer Center
Fargo, North Dakota
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio
- Call 412-784-4900
UPMC-Saint Margaret
Pittsburgh, Pennsylvania
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IRMC Cancer Center
Indiana, Pennsylvania
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UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania
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UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania
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UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania
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UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania
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UPMC-Passavant Hospital
Pittsburgh, Pennsylvania
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- Call 412-502-3920
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania
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Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania
- Call 412-621-2334
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania
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Carlisle Regional Cancer Center
Carlisle, Pennsylvania
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UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania
- Call 814-676-7900
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania
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- Call 724-838-1900
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania
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UPMC Cancer Center-Washington
Washington, Pennsylvania
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UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania
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UPMC Hillman Cancer Center Erie
Erie, Pennsylvania
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota
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Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee
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Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee
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Essentia Health-Spooner Clinic
Spooner, Wisconsin
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Essentia Health-Hayward Clinic
Hayward, Wisconsin
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Northwest Wisconsin Cancer Center
Ashland, Wisconsin
- Call 701-364-6272
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin
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Duluth Clinic Ashland
Ashland, Wisconsin
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Trial data sourced from ClinicalTrials.gov.