NCT00003313

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_3

Geographic Reach
2 countries

264 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

November 26, 2003

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

November 19, 2014

Conditions

Keywords

stage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceroral complicationsdrug/agent toxicity by tissue/organradiation toxicity

Study Arms (2)

Arm 1

EXPERIMENTAL

Radiation therapy and chemotherapy + Amifostine

Biological: filgrastimDrug: amifostine trihydrateDrug: carboplatinDrug: paclitaxelRadiation: radiation therapy

Arm 2

ACTIVE COMPARATOR

Radiation therapy and chemotherapy alone

Biological: filgrastimDrug: carboplatinDrug: paclitaxelRadiation: radiation therapy

Interventions

filgrastimBIOLOGICAL
Arm 1Arm 2
Arm 1Arm 2
Arm 1Arm 2
Arm 1Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (264)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Huntsville Hospital System

Huntsville, Alabama, 35801-4470, United States

Location

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

Alabama Oncology, LLC

Montgomery, Alabama, 36106-2801, United States

Location

Radiation Oncology Associates of West Alabama

Tuscallosa, Alabama, 35401, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Mount Diablo Medical Center

Concord, California, 94524-4110, United States

Location

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

California Cancer Center

Fresno, California, 93720, United States

Location

Saint Agnes Cancer Center

Fresno, California, 93720, United States

Location

Glendale Memorial Hospital and Health Center

Glendale, California, 91204, United States

Location

Sutter Health West Cancer Research Group

Greenbrae, California, 94904, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Huntington Cancer Center

Pasadena, California, 91105, United States

Location

Cancer Care Center

Pomona, California, 91767, United States

Location

Radiation Oncology Center - Sacramento

Sacramento, California, 95816, United States

Location

Radiation Medical Group, Inc.

San Diego, California, 92101-1492, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

O'Connor Hospital

San Jose, California, 95128, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Saint Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Lykes Center for Radiation Therapy

Clearwater, Florida, 33757-0210, United States

Location

Halifax Medical Center

Daytona Beach, Florida, 32114, United States

Location

Radiation Therapy Associates - Fort Myers

Fort Myers, Florida, 33901, United States

Location

University of Florida Health Science Center

Gainesville, Florida, 32610-0296, United States

Location

Health First Holmes Regional Medical Center

Melbourne, Florida, 32901, United States

Location

Veterans Affairs Medical Center - Miami

Miami, Florida, 33125, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176-2197, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Radiation Oncology Group

Orange Park, Florida, 32073, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Bay Medical Center

Panama City, Florida, 32401, United States

Location

Gulf Coast Cancer Treatment Center

Panama City, Florida, 32405-4587, United States

Location

Sarasota Radiation and Medical Oncology Center

Sarasota, Florida, 34233, United States

Location

Tallahassee Memorial Healthcare

Tallahassee, Florida, 32308, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Medical Center/John B. Amos Community Cancer Center

Columbus, Georgia, 31902, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Provena St. Joseph Hospital- Regional Cancer Care Center

Elgin, Illinois, 60123, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

St. John's Medical Center

Anderson, Indiana, 46016, United States

Location

Bloomington Hospital

Bloomington, Indiana, 47402, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

Clarion Health Partners Inc.

Indianapolis, Indiana, 46206-1367, United States

Location

Community Hospitals of Indianapolis - Regional Cancer Center

Indianapolis, Indiana, 46219, United States

Location

Ball Memorial Hospital

Muncie, Indiana, 47303-3499, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Wendt Regional Cancer Center of Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40511-1093, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Louisville Radiation Oncology

Louisville, Kentucky, 40215, United States

Location

Merle M. Mahr Cancer Center

Madisonville, Kentucky, 42431, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Romagosa Radiation Oncology Center

Lafayette, Louisiana, 70501, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Anne Arundel Oncology Center

Annapolis, Maryland, 21401, United States

Location

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, 21204, United States

Location

Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21225, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Radiation Oncology Affiliates of Maryland, P.A.

Baltimore, Maryland, 21237, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, 02130, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

McLaren Regional Cancer Center

Flint, Michigan, 48432, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

MidMichigan Medical Center - Midland

Midland, Michigan, 48670, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Mary's Medical Center

Saginaw, Michigan, 48601, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48098, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

North Mississippi Medical Center/Cancer Center

Tupelo, Mississippi, 38801, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Nebraska Health System

Omaha, Nebraska, 68105-1018, United States

Location

Methodist Cancer Center - Omaha

Omaha, Nebraska, 68114, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Elliot Regional Cancer Center

Manchester, New Hampshire, 03103, United States

Location

Cooper Cancer Institute

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

John F. Kennedy Medical Center

Edison, New Jersey, 08818, United States

Location

Trinitas Hospital - Jersey Street Campus

Elizabeth, New Jersey, 07201, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

South Jersey Regional Cancer Center

Millville, New Jersey, 08332, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Atlantic City Medical Center

Pomona, New Jersey, 08240, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Associated Radiologists, P.A.

Warren Township, New Jersey, 07059, United States

Location

Saint Joseph Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215-3609, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Finger Lakes Radiation Oncology, P.C.

Clifton Springs, New York, 14432, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Champlain Valley Physicians Hospital Medical Center

Plattsburgh, New York, 12901, United States

Location

Vassar Brothers Hospital

Poughkeepsie, New York, 12601, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Riverhill Radiation Oncology

Yonkers, New York, 10701, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Catawba Memorial Hospital

Hickory, North Carolina, 28601, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Meritcare Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Trinity Cancer Care Center

Minot, North Dakota, 58701, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

St. Anthony Hospital

Oklahoma City, Oklahoma, 73101, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

St. John Health System

Tulsa, Oklahoma, 74104, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

St. Luke's Hospital Regional Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Fitzgerald Mercy Hospital

Darby, Pennsylvania, 19023, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Pocono Cancer Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Penn State Geisinger Cancer Center

Hershey, Pennsylvania, 17033, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Veterans Affairs Medical Center - Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, 18501, United States

Location

Grand View Hospital

Sellersville, Pennsylvania, 18960, United States

Location

Wilkes Barre General Hospital

Wilkes-Barre, Pennsylvania, 18764, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

York Hospital

York, Pennsylvania, 17315, United States

Location

Roger Williams Medical Center/BUSM

Providence, Rhode Island, 02908-4735, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, 38103, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Julie and Ben Rogers Cancer Institute

Beaumont, Texas, 77701, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Wilford Hall - 59th Medical Wing

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Bayshore Medical Center

Pasadena, Texas, 77504, United States

Location

East Texas Medical Center - Cancer Institute

Tyler, Texas, 75701, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

CCOP - Southwestern Vermont Regional Cancer Center

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Green Mountain Oncology Group

Rutland, Vermont, 05701, United States

Location

Martha Jefferson Hospital

Charlottesville, Virginia, 22901, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

RMH Regional Canter Center

Harrisonburg, Virginia, 22801, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Bon-Secours - St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Medical Foundation

La Crosse, Wisconsin, 54601, United States

Location

Southern Wisconsin Radiotherapy Center

Madison, Wisconsin, 53713, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Community Memorial Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

St. Joseph's Hospital

Milwaukee, Wisconsin, 53210, United States

Location

Columbia Hospital

Milwaukee, Wisconsin, 53211, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Southeastern Wisconsin Regional Cancer Center

Racine, Wisconsin, 53405, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 1C4, Canada

Location

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (15)

  • Machtay M, Bae K, Movsas B, Paulus R, Gore EM, Komaki R, Albain K, Sause WT, Curran WJ. Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):425-34. doi: 10.1016/j.ijrobp.2010.09.004. Epub 2010 Oct 25.

    PMID: 20980108BACKGROUND
  • Siddiqui F, Bae K, Langer CJ, Coyne JC, Gamerman V, Komaki R, Choy H, Curran WJ, Watkins-Bruner D, Movsas B. The influence of gender, race, and marital status on survival in lung cancer patients: analysis of Radiation Therapy Oncology Group trials. J Thorac Oncol. 2010 May;5(5):631-9. doi: 10.1097/jto.0b013e3181d5e46a.

    PMID: 20432520BACKGROUND
  • Bruner DW. Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr. 2007;(37):12-5. doi: 10.1093/jncimonographs/lgm004.

    PMID: 17951225BACKGROUND
  • Langer CJ, Swann S, Curran W, et al.: Reassessing prognostic factors in the era of combined modality therapy for locally advanced NSCLC: a retrospective analysis of RTOG 9410 and 9801. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-65, S39, 2005.

    BACKGROUND
  • Machtay M, Swann S, Komaki R, et al.: What is the meaning of local-regional control after chemoradiation for locally advanced NSCLC? An RTOG analysis. [Abstract] Lung Cancer 50 (Suppl 2): A-O-041, S17, 2005.

    BACKGROUND
  • Sause W, Scott C, Byhardt R, et al.: Combined chemotheray radiation therapy treatment in unresected non-small cell lung cancer: Radiation Therapy Oncology Group (RTOG) experience. Lung Cancer 29(suppl 2): 2000.

    BACKGROUND
  • Movsas B, Moughan J, Sarna L, Langer C, Werner-Wasik M, Nicolaou N, Komaki R, Machtay M, Wasserman T, Bruner DW. Quality of life supersedes the classic prognosticators for long-term survival in locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. J Clin Oncol. 2009 Dec 1;27(34):5816-22. doi: 10.1200/JCO.2009.23.7420. Epub 2009 Oct 26.

  • Sarna L, Swann S, Langer C, Werner-Wasik M, Nicolaou N, Komaki R, Machtay M, Byhardt R, Wasserman T, Movsas B. Clinically meaningful differences in patient-reported outcomes with amifostine in combination with chemoradiation for locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1378-84. doi: 10.1016/j.ijrobp.2008.03.003. Epub 2008 May 22.

  • Movsas B, Scott C, Langer C, Werner-Wasik M, Nicolaou N, Komaki R, Machtay M, Smith C, Axelrod R, Sarna L, Wasserman T, Byhardt R. Randomized trial of amifostine in locally advanced non-small-cell lung cancer patients receiving chemotherapy and hyperfractionated radiation: radiation therapy oncology group trial 98-01. J Clin Oncol. 2005 Apr 1;23(10):2145-54. doi: 10.1200/JCO.2005.07.167.

  • Nicolaou N, Moughan J, Sarna L, et al.: Quality of life (QOL) supercedes the classic predictors of survival in locally advanced non-small cell lung cancer (NSCLC): an analysis of Radiation Therapy Oncology Group (RTOG) 9801. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-103, S58-59, 2007.

    RESULT
  • Sarna L, Swann S, Langer C, et al.: Is there a "disconnect" between physician and patient - reported outcomes (PROs): an analysis of RTOG 98-01. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2595, S541, 2006.

    RESULT
  • Werner-Wasik M, Langer C, Movsas B. Amifostine in chemoradiation therapy for non-small cell lung cancer: review of experience and design of a phase II trial assessing subcutaneous and intravenous bolus administration. Semin Oncol. 2005 Apr;32(2 Suppl 3):S105-8. doi: 10.1053/j.seminoncol.2005.03.018.

  • Werner-Wasik M, Scott C, Movsas B, et al.: Amifostine as mucosal protectant in patients with locally advanced non-small cell lung cancer (NSCLC) receiving intensive chemotherapy and thoracic radiotherapy (RT): results of the radiation therapy oncology group (RTOG) 98-01 study. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S216, 2003.

    RESULT
  • Movsas B. Exploring the role of the radioprotector amifostine in locally advanced non-small cell lung cancer: Radiation Therapy Oncology Group trial 98-01. Semin Radiat Oncol. 2002 Jan;12(1 Suppl 1):40-5. doi: 10.1053/srao.2002.31362.

  • Lawrence YR, Paulus R, Langer C, Werner-Wasik M, Buyyounouski MK, Komaki R, Machtay M, Smith C, Axelrod RS, Wasserman T, Bradley JD, Movsas B. The addition of amifostine to carboplatin and paclitaxel based chemoradiation in locally advanced non-small cell lung cancer: long-term follow-up of Radiation Therapy Oncology Group (RTOG) randomized trial 9801. Lung Cancer. 2013 Jun;80(3):298-305. doi: 10.1016/j.lungcan.2013.02.008. Epub 2013 Mar 7.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLung NeoplasmsRadiation InjuriesCarcinoma, Non-Small-Cell Lung

Interventions

FilgrastimAmifostineCarboplatinPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesWounds and InjuriesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsOrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsCoordination ComplexesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Benjamin Movsas, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

November 26, 2003

Study Start

September 1, 1998

Primary Completion

July 1, 2002

Study Completion

June 1, 2010

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations