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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003313 |
Purpose
RATIONALE: Amifostine may be an effective treatment for the toxic side effects caused by radiation therapy and chemotherapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of amifostine in treating patients who have stage II or stage III non-small cell lung cancer that cannot be surgically removed and who are undergoing chemotherapy and radiation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Lung Cancer Oral Complications Radiation Toxicity |
Biological: filgrastim Drug: amifostine trihydrate Drug: carboplatin Drug: paclitaxel Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | A Phase III Randomized Study of Amifostine Mucosal Protection for Patients With Favorable Performance Inoperable Stage II-III A/B Non-Small Cell Lung Cancer (NSCLC) Receiving Sequential Induction and Concurrent Hyperfractionated Radiotherapy With Paclitaxel and Carboplatin |
| Estimated Enrollment: | 244 |
| Study Start Date: | September 1998 |
OBJECTIVES: I. Evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of non-hematologic toxicity, specifically esophagitis and pneumonitis, during concurrent hyperfractionated radiotherapy and chemotherapy (with paclitaxel and carboplatin) in patients with stage II, IIIA, or IIIB non-small cell lung cancer. II. Evaluate the differences in quality of life and symptom distress, specifically dysphagia, between patients receiving amifostine and those not receiving amifostine. III. Evaluate the relationship of tobacco use and alcohol use during treatment to appraisals of quality of life and symptom distress, specifically esophagitis, in the two groups. IV. Evaluate the efficacy of induction therapy with paclitaxel and carboplatin followed by concurrent chemotherapy and hyperfractionated radiotherapy in these patients.
OUTLINE: This is an open-label treatment and randomized supportive care study. Patients are stratified according to disease stage (II vs IIIA vs IIIB), Karnofsky performance status (90-100% vs 70-80%), and age (70 and under vs over 70). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on days 1 and 22 and over 1 hour weekly for 6 weeks beginning on day 43. Patients receive carboplatin IV over 30 minutes immediately after each paclitaxel dose. Patients receive filgrastim (G-CSF) subcutaneously for 10-14 days after each of the first two paclitaxel and carboplatin doses. Radiotherapy begins on day 43 and is administered twice daily for 5 days per week for 6 weeks. Beginning on day 43, patients receive amifostine IV over 5-7 minutes 4 days a week for 6 weeks. Arm II: Patients receive treatment as in arm I without amifostine. Quality of life is assessed at baseline, before chemoradiation (after 2 courses of induction chemotherapy), the last week of chemoradiation (week 6), and at the 6-week follow-up visit. Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 244 patients (122 per treatment arm) will be accrued for this study within 38 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage II, IIIA, or IIIB non-small cell lung cancer No distant metastases No prior complete (or gross subtotal) tumor resection No post-resection intrathoracic tumor recurrence Pleural effusion seen on a chest x-ray allowed only if appearing after thoracotomy or other invasive thoracic procedure (pleural effusion acceptable if seen only on CT scan, not on chest x-ray) Must be ineligible or refused participation in protocol RTOG-9309
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL* SGOT no greater than 1.5 times upper limit of normal* * Unless due to documented benign disease Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmias Other: No weight loss of greater than 5% in 3 months prior to diagnosis No other prior or concurrent invasive malignancy within the past 3 years except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck radiotherapy Surgery: See Disease Characteristics
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Alabama Oncology, LLC | |
| Montgomery, Alabama, United States, 36106-2801 | |
| Comprehensive Cancer Institute of Huntsville | |
| Huntsville, Alabama, United States, 35801 | |
| Huntsville Hospital System | |
| Huntsville, Alabama, United States, 35801-4470 | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| Radiation Oncology Associates of West Alabama | |
| Tuscallosa, Alabama, United States, 35401 | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Alaska | |
| Providence Alaska Medical Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| Foundation for Cancer Research and Education | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| California Cancer Center | |
| Fresno, California, United States, 93720 | |
| Cancer Care Center | |
| Pomona, California, United States, 91767 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Cancer Center and Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010-3000 | |
| Glendale Memorial Hospital and Health Center | |
| Glendale, California, United States, 91204 | |
| Huntington Cancer Center | |
| Pasadena, California, United States, 91105 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Mount Diablo Medical Center | |
| Concord, California, United States, 94524-4110 | |
| Saint Agnes Cancer Center | |
| Fresno, California, United States, 93720 | |
| Radiation Medical Group, Inc. | |
| San Diego, California, United States, 92101-1492 | |
| Radiation Oncology Center - Sacramento | |
| Sacramento, California, United States, 95816 | |
| O'Connor Hospital | |
| San Jose, California, United States, 95128 | |
| Sutter Health West Cancer Research Group | |
| Greenbrae, California, United States, 94904 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Veterans Affairs Medical Center - Long Beach | |
| Long Beach, California, United States, 90822 | |
| United States, Colorado | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| Saint Mary's Hospital and Medical Center | |
| Grand Junction, Colorado, United States, 81502 | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| Baptist Hospital of Miami | |
| Miami, Florida, United States, 33176-2197 | |
| Bay Medical Center | |
| Panama City, Florida, United States, 32401 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Florida Radiation Oncology Group | |
| Orange Park, Florida, United States, 32073 | |
| Gulf Coast Cancer Treatment Center | |
| Panama City, Florida, United States, 32405-4587 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| Halifax Medical Center | |
| Daytona Beach, Florida, United States, 32114 | |
| University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-0296 | |
| Lykes Center for Radiation Therapy | |
| Clearwater, Florida, United States, 33757-0210 | |
| MD Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| Radiation Therapy Associates - Fort Myers | |
| Fort Myers, Florida, United States, 33901 | |
| Sarasota Radiation and Medical Oncology Center | |
| Sarasota, Florida, United States, 34233 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| Tallahassee Memorial Healthcare | |
| Tallahassee, Florida, United States, 32308 | |
| Health First Holmes Regional Medical Center | |
| Melbourne, Florida, United States, 32901 | |
| Veterans Affairs Medical Center - Miami | |
| Miami, Florida, United States, 33125 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Medical Center/John B. Amos Community Cancer Center | |
| Columbus, Georgia, United States, 31902 | |
| Regional Radiation Oncology Center at Rome | |
| Rome, Georgia, United States, 30165 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Northwest Community Hospital | |
| Arlington Heights, Illinois, United States, 60005 | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| Provena St. Joseph Hospital- Regional Cancer Care Center | |
| Elgin, Illinois, United States, 60123 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Ball Memorial Hospital | |
| Muncie, Indiana, United States, 47303-3499 | |
| Bloomington Hospital | |
| Bloomington, Indiana, United States, 47402 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Clarion Health Partners Inc. | |
| Indianapolis, Indiana, United States, 46206-1367 | |
| Community Hospitals of Indianapolis - Regional Cancer Center | |
| Indianapolis, Indiana, United States, 46219 | |
| St. John's Medical Center | |
| Anderson, Indiana, United States, 46016 | |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at The University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| Wendt Regional Cancer Center of Finley Hospital | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| Louisville Radiation Oncology | |
| Louisville, Kentucky, United States, 40215 | |
| Merle M. Mahr Cancer Center | |
| Madisonville, Kentucky, United States, 42431 | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40511-1093 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Romagosa Radiation Oncology Center | |
| Lafayette, Louisiana, United States, 70501 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Anne Arundel Oncology Center | |
| Annapolis, Maryland, United States, 21401 | |
| Radiation Oncology Affiliates of Maryland, P.A. | |
| Baltimore, Maryland, United States, 21237 | |
| Harbor Hospital Center | |
| Baltimore, Maryland, United States, 21225 | |
| Peninsula Regional Medical Center | |
| Salisbury, Maryland, United States, 21801 | |
| Greater Baltimore Medical Center and Cancer Center | |
| Baltimore, Maryland, United States, 21204 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21225 | |
| United States, Massachusetts | |
| Cape Cod Hospital | |
| Hyannis, Massachusetts, United States, 02601 | |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Marquette General Hospital | |
| Marquette, Michigan, United States, 49855 | |
| McLaren Regional Cancer Center | |
| Flint, Michigan, United States, 48432 | |
| MidMichigan Medical Center - Midland | |
| Midland, Michigan, United States, 48670 | |
| St. Mary's Medical Center | |
| Saginaw, Michigan, United States, 48601 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| William Beaumont Hospital - Troy | |
| Troy, Michigan, United States, 48098 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| North Mississippi Medical Center/Cancer Center | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Mallinckrodt Institute of Radiology | |
| Saint Louis, Missouri, United States, 63110 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Methodist Cancer Center - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| Nebraska Health System | |
| Omaha, Nebraska, United States, 68105-1018 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Elliot Regional Cancer Center | |
| Manchester, New Hampshire, United States, 03103 | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Associated Radiologists, P.A. | |
| Warren, New Jersey, United States, 07059 | |
| Atlantic City Medical Center | |
| Pomona, New Jersey, United States, 08240 | |
| Somerset Medical Center | |
| Somerville, New Jersey, United States, 08876 | |
| Community Medical Center | |
| Toms River, New Jersey, United States, 08755 | |
| Cooper Cancer Institute | |
| Camden, New Jersey, United States, 08103 | |
| Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | |
| Mount Holly, New Jersey, United States, 08060 | |
| John F. Kennedy Medical Center | |
| Edison, New Jersey, United States, 08818 | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States, 07740-6395 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| South Jersey Regional Cancer Center | |
| Millville, New Jersey, United States, 08332 | |
| St. Francis Medical Center | |
| Trenton, New Jersey, United States, 08629 | |
| Trinitas Hospital - Jersey Street Campus | |
| Elizabeth, New Jersey, United States, 07201 | |
| Valley Hospital | |
| Ridgewood, New Jersey, United States, 07450 | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| United States, New Mexico | |
| Saint Joseph Medical Center | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| Cancer Center of Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| New York Methodist Hospital | |
| Brooklyn, New York, United States, 11215-3609 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| Champlain Valley Physicians Hospital Medical Center | |
| Plattsburgh, New York, United States, 12901 | |
| Finger Lakes Radiation Oncology, P.C. | |
| Clifton Springs, New York, United States, 14432 | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Riverhill Radiation Oncology | |
| Yonkers, New York, United States, 10701 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| State University of New York Health Science Center at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| Vassar Brothers Hospital | |
| Poughkeepsie, New York, United States, 12601 | |
| United States, North Carolina | |
| Catawba Memorial Hospital | |
| Hickory, North Carolina, United States, 28601 | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Northeast Medical Center | |
| Concord, North Carolina, United States, 28025 | |
| United States, North Dakota | |
| Meritcare Roger Maris Cancer Center | |
| Fargo, North Dakota, United States, 58122 | |
| Trinity Cancer Care Center | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44309 | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44302 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| St. Anthony Hospital | |
| Oklahoma City, Oklahoma, United States, 73101 | |
| St. John Health System | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Delaware County Memorial Hospital | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Fitzgerald Mercy Hospital | |
| Darby, Pennsylvania, United States, 19023 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Wilkes Barre General Hospital | |
| Wilkes-Barre, Pennsylvania, United States, 18764 | |
| Grand View Hospital | |
| Sellersville, Pennsylvania, United States, 18960 | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
| Mercy Hospital Cancer Center - Scranton | |
| Scranton, Pennsylvania, United States, 18501 | |
| Mercy Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Penn State Geisinger Cancer Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Pocono Cancer Center | |
| East Stroudsburg, Pennsylvania, United States, 18301 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| St. Luke's Hospital Regional Cancer Center | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| Veterans Affairs Medical Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| York Hospital | |
| York, Pennsylvania, United States, 17315 | |
| United States, Rhode Island | |
| Roger Williams Medical Center/BUSM | |
| Providence, Rhode Island, United States, 02908-4735 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| United States, Tennessee | |
| Jackson-Madison County General Hospital | |
| Jackson, Tennessee, United States, 38301 | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38103 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Wilford Hall - 59th Medical Wing | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| East Texas Medical Center - Cancer Institute | |
| Tyler, Texas, United States, 75701 | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| Julie and Ben Rogers Cancer Institute | |
| Beaumont, Texas, United States, 77701 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0209 | |
| Bayshore Medical Center | |
| Pasadena, Texas, United States, 77504 | |
| United States, Utah | |
| Dixie Regional Medical Center | |
| Saint George, Utah, United States, 84770 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| University of Utah Health Sciences Center | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Vermont | |
| CCOP - Southwestern Vermont Regional Cancer Center | |
| Bennington, Vermont, United States, 05201 | |
| Green Mountain Oncology Group | |
| Rutland, Vermont, United States, 05701 | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| Bon-Secours - St. Mary's Hospital | |
| Richmond, Virginia, United States, 23226 | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Martha Jefferson Hospital | |
| Charlottesville, Virginia, United States, 22901 | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Naval Medical Center, Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| RMH Regional Canter Center | |
| Harrisonburg, Virginia, United States, 22801 | |
| United States, Washington | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98111 | |
| Yakima Valley Memorial Hospital | |
| Yakima, Washington, United States, 98902 | |
| United States, West Virginia | |
| Schiffler Cancer Center | |
| Wheeling, West Virginia, United States, 26003 | |
| United States, Wisconsin | |
| Columbia Hospital | |
| Milwaukee, Wisconsin, United States, 53211 | |
| Community Memorial Hospital | |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| Gundersen Lutheran Medical Foundation | |
| La Crosse, Wisconsin, United States, 54601 | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Southern Wisconsin Radiotherapy Center | |
| Madison, Wisconsin, United States, 53713 | |
| St. Joseph's Hospital | |
| Milwaukee, Wisconsin, United States, 53210 | |
| Southeastern Wisconsin Regional Cancer Center | |
| Racine, Wisconsin, United States, 53405 | |
| St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Waukesha Memorial Hospital | |
| Waukesha, Wisconsin, United States, 53188 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, New Brunswick | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Treatment and Research Foundation | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Regional Cancer Centre - General Campus | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Northeastern Ontario Regional Cancer Centre, Sudbury | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Northwestern Ontario Regional Cancer Centre, Thunder Bay | |
| Thunder Bay, Ontario, Canada, P7A 7T1 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L-4M1 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| CHUS-Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Study Chair: | Benjamin Movsas, MD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000066260, RTOG-9801 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003313 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
oral complications drug/agent toxicity by tissue/organ radiation toxicity |
|
Thoracic Neoplasms Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Respiratory Tract Neoplasms Neoplasms by Histologic Type Amifostine Mitosis Modulators |
Carboplatin Antimitotic Agents Protective Agents Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
