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Spots Global Cancer Trial Database for Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

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Trial Identification

Brief Title: Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

Official Title: A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).

Study ID: NCT00153803

Study Description

Brief Summary: This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

Detailed Description: The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Birmingham Hematology and Oncology Associates, LLC, Birmingham, Alabama, United States

Oncology Specialties, P.C., Huntsville, Alabama, United States

Cooper Clinic, Fort Smith, Arkansas, United States

Genesis Cancer Center, Hot Springs, Arkansas, United States

Alta Bates Comprehensive Cancer Center, Berkeley, California, United States

Northstate Cancer Speciality, Redding, California, United States

Mercy General Hospital, Sacramento, California, United States

St. Francis Hospital Cancer Center, Hartford, Connecticut, United States

Connecticut Oncology Group, Middletown, Connecticut, United States

George Bray Cancer Center/New Britain General Hospital, New Britain, Connecticut, United States

Oncology and Hematology Associates, PC, New London, Connecticut, United States

Whittingham Cancer Center at Norwalk Hospital, Norwalk, Connecticut, United States

Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center, Stamford, Connecticut, United States

Washington Cancer Institute, Washington, District of Columbia, United States

Pasco Hernando Oncology Associates, Brooksville, Florida, United States

Florida Cancer Specialists, Fort Myers, Florida, United States

Lee Cancer Clinic, Fort Myers, Florida, United States

Jupiter Medical Center, Jupiter, Florida, United States

Cancer Care of North Florida, Lake City, Florida, United States

Pasco/Hernando Oncology, New Port Richey, Florida, United States

Mid Florida Oncology, Orange City, Florida, United States

MD Anderson, Orlando, Florida, United States

Oncology & Hematology Association of West Broward, Tamarac, Florida, United States

Palm Beach Cancer Institute, West Palm Beach, Florida, United States

Alexian Brothers Hospital Network, Elk Grove Village, Illinois, United States

Joliet Hematology Associates, Joliet, Illinois, United States

Investigative Clinical Research of Indiana LLC, Indianapolis, Indiana, United States

Howard Regional Health System, Kokomo, Indiana, United States

McFarland Clinic, Ames, Iowa, United States

Kentucky Cancer Clinic, Hazard, Kentucky, United States

Western Hematology Oncology, Paducah, Kentucky, United States

Maine Center for Cancer Medicine, Scarborough, Maine, United States

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Union Memorial Hospital, Baltimore, Maryland, United States

Harbor View Cancer Center, Baltimore, Maryland, United States

Franklin Square Hospital Center, Baltimore, Maryland, United States

Frederick Smith, MD, Chevy Chase, Maryland, United States

Community Hematology Oncology, Olney, Maryland, United States

Lahey Clinic Medical Center, Burlington, Massachusetts, United States

Fallon Clinic Hematology/ Oncology, Worcester, Massachusetts, United States

Bay Medical Cancer Center, Bay City, Michigan, United States

Southeast Nebraska Hematology/Oncology, Lincoln, Nebraska, United States

Methodist Cancer Center, Omaha, Nebraska, United States

Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Dartmouth-Hitchcock-Keene, Keene, New Hampshire, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

The Center for Cancer and Hematologic Disease, Cherry Hill, New Jersey, United States

Sussex County Medical Associates, Newton, New Jersey, United States

Lincoln Hospital, Bronx, New York, United States

Queens Medical Associates, Fresh Meadows, New York, United States

Winthrop University Hospital, Mineola, New York, United States

Hematology Oncology Associates of Rockland, PC, New York, New York, United States

Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States

Aultman Cancer Center, Canton, Ohio, United States

The Cleveland Clinic Foundation Hematology/Med Oncology, Cleveland, Ohio, United States

Legacy Good Samaritan, Portland, Oregon, United States

SCOA-SC Onc Assoc, Columbia, South Carolina, United States

VA Department of Hematology/Oncology, Houston, Texas, United States

Hope Oncology, Richardson, Texas, United States

Blood and Cancer Center of East Texas, Tyler, Texas, United States

Tyler Hematology/Oncology, Tyler, Texas, United States

Veterans Administration Medical Center, White River Junction, Vermont, United States

Virginia Oncology Associates Research Program, Newport News, Virginia, United States

Olympic Hematology/Oncology, Bremerton, Washington, United States

Morgantown Internal Medicine Group, Morgantown, West Virginia, United States

Contact Details

Name: James R Rigas, MD

Affiliation: Norris Cotton Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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