Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer

NCT ID: NCT00003313

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Drug/Agent Toxicity by Tissue/Organ Lung Cancer Oral Complications Radiation Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm 1

Radiation therapy and chemotherapy + Amifostine

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

amifostine trihydrate

Intervention Type DRUG

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Arm 2

Radiation therapy and chemotherapy alone

Group Type ACTIVE_COMPARATOR

filgrastim

Intervention Type BIOLOGICAL

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Interventions

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filgrastim

Intervention Type BIOLOGICAL

amifostine trihydrate

Intervention Type DRUG

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NRG Oncology

OTHER

Sponsor Role collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Movsas, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

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University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Huntsville Hospital System

Huntsville, Alabama, United States

Site Status

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, United States

Site Status

MBCCOP - Gulf Coast

Mobile, Alabama, United States

Site Status

Alabama Oncology, LLC

Montgomery, Alabama, United States

Site Status

Radiation Oncology Associates of West Alabama

Tuscallosa, Alabama, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Foundation for Cancer Research and Education

Phoenix, Arizona, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Mount Diablo Medical Center

Concord, California, United States

Site Status

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, United States

Site Status

California Cancer Center

Fresno, California, United States

Site Status

Saint Agnes Cancer Center

Fresno, California, United States

Site Status

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Site Status

Sutter Health West Cancer Research Group

Greenbrae, California, United States

Site Status

University of California San Diego Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Veterans Affairs Medical Center - Long Beach

Long Beach, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Huntington Cancer Center

Pasadena, California, United States

Site Status

Cancer Care Center

Pomona, California, United States

Site Status

Radiation Oncology Center - Sacramento

Sacramento, California, United States

Site Status

Radiation Medical Group, Inc.

San Diego, California, United States

Site Status

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Site Status

O'Connor Hospital

San Jose, California, United States

Site Status

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status

David Grant Medical Center

Travis Air Force Base, California, United States

Site Status

Memorial Hospital Cancer Center

Colorado Springs, Colorado, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

Saint Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Lykes Center for Radiation Therapy

Clearwater, Florida, United States

Site Status

Halifax Medical Center

Daytona Beach, Florida, United States

Site Status

Radiation Therapy Associates - Fort Myers

Fort Myers, Florida, United States

Site Status

University of Florida Health Science Center

Gainesville, Florida, United States

Site Status

Health First Holmes Regional Medical Center

Melbourne, Florida, United States

Site Status

Veterans Affairs Medical Center - Miami

Miami, Florida, United States

Site Status

Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Florida Radiation Oncology Group

Orange Park, Florida, United States

Site Status

MD Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

Bay Medical Center

Panama City, Florida, United States

Site Status

Gulf Coast Cancer Treatment Center

Panama City, Florida, United States

Site Status

Sarasota Radiation and Medical Oncology Center

Sarasota, Florida, United States

Site Status

Tallahassee Memorial Healthcare

Tallahassee, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

Medical Center/John B. Amos Community Cancer Center

Columbus, Georgia, United States

Site Status

Regional Radiation Oncology Center at Rome

Rome, Georgia, United States

Site Status

MBCCOP - Hawaii

Honolulu, Hawaii, United States

Site Status

Northwest Community Hospital

Arlington Heights, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

CCOP - Central Illinois

Decatur, Illinois, United States

Site Status

Provena St. Joseph Hospital- Regional Cancer Care Center

Elgin, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

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Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

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Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

St. John's Medical Center

Anderson, Indiana, United States

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Bloomington Hospital

Bloomington, Indiana, United States

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Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, United States

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Clarion Health Partners Inc.

Indianapolis, Indiana, United States

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Community Hospitals of Indianapolis - Regional Cancer Center

Indianapolis, Indiana, United States

Site Status

Ball Memorial Hospital

Muncie, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

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Wendt Regional Cancer Center of Finley Hospital

Dubuque, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, United States

Site Status

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, United States

Site Status

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Louisville Radiation Oncology

Louisville, Kentucky, United States

Site Status

Merle M. Mahr Cancer Center

Madisonville, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

Romagosa Radiation Oncology Center

Lafayette, Louisiana, United States

Site Status

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status

CCOP - Ochsner

New Orleans, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

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Anne Arundel Oncology Center

Annapolis, Maryland, United States

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Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, United States

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Harbor Hospital Center

Baltimore, Maryland, United States

Site Status

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Radiation Oncology Affiliates of Maryland, P.A.

Baltimore, Maryland, United States

Site Status

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Site Status

Cape Cod Hospital

Hyannis, Massachusetts, United States

Site Status

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, United States

Site Status

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

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Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

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McLaren Regional Cancer Center

Flint, Michigan, United States

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Hurley Medical Center

Flint, Michigan, United States

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CCOP - Kalamazoo

Kalamazoo, Michigan, United States

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Marquette General Hospital

Marquette, Michigan, United States

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MidMichigan Medical Center - Midland

Midland, Michigan, United States

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William Beaumont Hospital

Royal Oak, Michigan, United States

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St. Mary's Medical Center

Saginaw, Michigan, United States

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William Beaumont Hospital - Troy

Troy, Michigan, United States

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Mayo Clinic Cancer Center

Rochester, Minnesota, United States

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CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

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North Mississippi Medical Center/Cancer Center

Tupelo, Mississippi, United States

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Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, United States

Site Status

CCOP - Kansas City

Kansas City, Missouri, United States

Site Status

Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

St. Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

Mallinckrodt Institute of Radiology

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Nebraska Health System

Omaha, Nebraska, United States

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Methodist Cancer Center - Omaha

Omaha, Nebraska, United States

Site Status

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Site Status

Elliot Regional Cancer Center

Manchester, New Hampshire, United States

Site Status

Cooper Cancer Institute

Camden, New Jersey, United States

Site Status

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Site Status

John F. Kennedy Medical Center

Edison, New Jersey, United States

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Trinitas Hospital - Jersey Street Campus

Elizabeth, New Jersey, United States

Site Status

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status

South Jersey Regional Cancer Center

Millville, New Jersey, United States

Site Status

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, United States

Site Status

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Atlantic City Medical Center

Pomona, New Jersey, United States

Site Status

Valley Hospital

Ridgewood, New Jersey, United States

Site Status

Somerset Medical Center

Somerville, New Jersey, United States

Site Status

Community Medical Center

Toms River, New Jersey, United States

Site Status

St. Francis Medical Center

Trenton, New Jersey, United States

Site Status

Associated Radiologists, P.A.

Warren Township, New Jersey, United States

Site Status

Saint Joseph Medical Center

Albuquerque, New Mexico, United States

Site Status

Cancer Center of Albany Medical Center

Albany, New York, United States

Site Status

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Finger Lakes Radiation Oncology, P.C.

Clifton Springs, New York, United States

Site Status

CCOP - North Shore University Hospital

Manhasset, New York, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Champlain Valley Physicians Hospital Medical Center

Plattsburgh, New York, United States

Site Status

Vassar Brothers Hospital

Poughkeepsie, New York, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

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

Syracuse, New York, United States

Site Status

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Riverhill Radiation Oncology

Yonkers, New York, United States

Site Status

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Site Status

Northeast Medical Center

Concord, North Carolina, United States

Site Status

East Carolina University School of Medicine

Greenville, North Carolina, United States

Site Status

Catawba Memorial Hospital

Hickory, North Carolina, United States

Site Status

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, United States

Site Status

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Meritcare Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Trinity Cancer Care Center

Minot, North Dakota, United States

Site Status

Akron General Medical Center

Akron, Ohio, United States

Site Status

Akron City Hospital

Akron, Ohio, United States

Site Status

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, United States

Site Status

Christ Hospital

Cincinnati, Ohio, United States

Site Status

Ireland Cancer Center

Cleveland, Ohio, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Site Status

CCOP - Dayton

Kettering, Ohio, United States

Site Status

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

Site Status

St. Anthony Hospital

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States

Site Status

St. John Health System

Tulsa, Oklahoma, United States

Site Status

CCOP - Columbia River Program

Portland, Oregon, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

St. Luke's Hospital Regional Cancer Center

Bethlehem, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Fitzgerald Mercy Hospital

Darby, Pennsylvania, United States

Site Status

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Site Status

Pocono Cancer Center

East Stroudsburg, Pennsylvania, United States

Site Status

Penn State Geisinger Cancer Center

Hershey, Pennsylvania, United States

Site Status

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Veterans Affairs Medical Center - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Site Status

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, United States

Site Status

Grand View Hospital

Sellersville, Pennsylvania, United States

Site Status

Wilkes Barre General Hospital

Wilkes-Barre, Pennsylvania, United States

Site Status

CCOP - MainLine Health

Wynnewood, Pennsylvania, United States

Site Status

York Hospital

York, Pennsylvania, United States

Site Status

Roger Williams Medical Center/BUSM

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Jackson-Madison County General Hospital

Jackson, Tennessee, United States

Site Status

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Julie and Ben Rogers Cancer Institute

Beaumont, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Wilford Hall - 59th Medical Wing

Lackland Air Force Base, Texas, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

Bayshore Medical Center

Pasadena, Texas, United States

Site Status

East Texas Medical Center - Cancer Institute

Tyler, Texas, United States

Site Status

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Dixie Regional Medical Center

St. George, Utah, United States

Site Status

CCOP - Southwestern Vermont Regional Cancer Center

Bennington, Vermont, United States

Site Status

Vermont Cancer Center

Burlington, Vermont, United States

Site Status

Green Mountain Oncology Group

Rutland, Vermont, United States

Site Status

Martha Jefferson Hospital

Charlottesville, Virginia, United States

Site Status

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Site Status

RMH Regional Canter Center

Harrisonburg, Virginia, United States

Site Status

Naval Medical Center, Portsmouth

Portsmouth, Virginia, United States

Site Status

Bon-Secours - St. Mary's Hospital

Richmond, Virginia, United States

Site Status

Massey Cancer Center

Richmond, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Deaconess Medical Center

Spokane, Washington, United States

Site Status

Yakima Valley Memorial Hospital

Yakima, Washington, United States

Site Status

Schiffler Cancer Center

Wheeling, West Virginia, United States

Site Status

St. Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Foundation

La Crosse, Wisconsin, United States

Site Status

Southern Wisconsin Radiotherapy Center

Madison, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Community Memorial Hospital

Menomonee Falls, Wisconsin, United States

Site Status

St. Joseph's Hospital

Milwaukee, Wisconsin, United States

Site Status

Columbia Hospital

Milwaukee, Wisconsin, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Site Status

Southeastern Wisconsin Regional Cancer Center

Racine, Wisconsin, United States

Site Status

Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Site Status

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Site Status

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, Canada

Site Status

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Site Status

Kingston Regional Cancer Centre

Kingston, Ontario, Canada

Site Status

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Site Status

Ottawa Regional Cancer Centre - General Campus

Ottawa, Ontario, Canada

Site Status

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, Canada

Site Status

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20980108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20432520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17951225 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 19858383 (View on PubMed)

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.

Reference Type RESULT
PMID: 18501528 (View on PubMed)

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.

Reference Type RESULT
PMID: 15800308 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 16015544 (View on PubMed)

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.

Reference Type 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.

Reference Type RESULT
PMID: 11917283 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23477890 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDR0000066260

Identifier Type: -

Identifier Source: secondary_id

RTOG-9801

Identifier Type: -

Identifier Source: org_study_id