Clinical trial NCT00003313: Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drug/Agent Toxicity by Tissue/Organ
Lung Cancer
Oral Complications
Radiation Toxicity
Keywords: 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
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2003-11-26
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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 criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital System
state: Alabama
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute of Huntsville
state: Alabama
city: Mobile
country: United States
facility: MBCCOP - Gulf Coast
state: Alabama
city: Montgomery
country: United States
facility: Alabama Oncology, LLC
state: Alabama
city: Tuscallosa
country: United States
facility: Radiation Oncology Associates of West Alabama
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Phoenix
country: United States
facility: Foundation for Cancer Research and Education
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Concord
country: United States
facility: Mount Diablo Medical Center
state: California
city: Duarte
country: United States
facility: Cancer Center and Beckman Research Institute, City of Hope
state: California
city: Fresno
country: United States
facility: California Cancer Center
state: California
city: Fresno
country: United States
facility: Saint Agnes Cancer Center
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Health Center
state: California
city: Greenbrae
country: United States
facility: Sutter Health West Cancer Research Group
state: California
city: La Jolla
country: United States
facility: University of California San Diego Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: Veterans Affairs Medical Center - Long Beach
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Oakland
country: United States
facility: CCOP - Bay Area Tumor Institute
state: California
city: Pasadena
country: United States
facility: Huntington Cancer Center
state: California
city: Pomona
country: United States
facility: Cancer Care Center
state: California
city: Sacramento
country: United States
facility: Radiation Oncology Center - Sacramento
state: California
city: San Diego
country: United States
facility: Radiation Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: San Jose
country: United States
facility: O'Connor Hospital
state: California
city: Santa Rosa
country: United States
facility: CCOP - Santa Rosa Memorial Hospital
state: California
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital Cancer Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Grand Junction
country: United States
facility: Saint Mary's Hospital and Medical Center
state: Colorado
city: Wilmington
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: Lykes Center for Radiation Therapy
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Medical Center
state: Florida
city: Fort Myers
country: United States
facility: Radiation Therapy Associates - Fort Myers
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Melbourne
country: United States
facility: Health First Holmes Regional Medical Center
state: Florida
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Veterans Affairs Medical Center - Miami
state: Florida
city: Miami
country: United States
facility: Sylvester Cancer Center, University of Miami
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orange Park
country: United States
facility: Florida Radiation Oncology Group
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Panama City
country: United States
facility: Bay Medical Center
state: Florida
city: Panama City
country: United States
facility: Gulf Coast Cancer Treatment Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Radiation and Medical Oncology Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Healthcare
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: CCOP - Atlanta Regional
state: Georgia
city: Columbus
country: United States
facility: Medical Center/John B. Amos Community Cancer Center
state: Georgia
city: Rome
country: United States
facility: Regional Radiation Oncology Center at Rome
state: Georgia
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Elgin
country: United States
facility: Provena St. Joseph Hospital- Regional Cancer Care Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Care Center
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Anderson
country: United States
facility: St. John's Medical Center
state: Indiana
city: Bloomington
country: United States
facility: Bloomington Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Veterans Affairs Medical Center - Indianapolis (Roudebush)
state: Indiana
city: Indianapolis
country: United States
facility: Clarion Health Partners Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Community Hospitals of Indianapolis - Regional Cancer Center
state: Indiana
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Dubuque
country: United States
facility: Wendt Regional Cancer Center of Finley Hospital
state: Iowa
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at The University of Iowa
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Lexington
country: United States
facility: Veterans Affairs Medical Center - Lexington
state: Kentucky
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center, University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Louisville Radiation Oncology
state: Kentucky
city: Madisonville
country: United States
facility: Merle M. Mahr Cancer Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Lafayette
country: United States
facility: Romagosa Radiation Oncology Center
state: Louisiana
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Oncology Center
state: Maryland
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center and Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Harbor Hospital Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: Radiation Oncology Affiliates of Maryland, P.A.
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Veterans Affairs Medical Center - Boston (Jamaica Plain)
state: Massachusetts
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: McLaren Regional Cancer Center
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Marquette
country: United States
facility: Marquette General Hospital
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center - Midland
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's Medical Center
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center/Cancer Center
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Health Sciences Center
state: Missouri
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: Billings
country: United States
facility: CCOP - Montana Cancer Consortium
state: Montana
city: Omaha
country: United States
facility: Nebraska Health System
state: Nebraska
city: Omaha
country: United States
facility: Methodist Cancer Center - Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Southern Nevada Cancer Research Foundation
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Manchester
country: United States
facility: Elliot Regional Cancer Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper Cancer Institute
state: New Jersey
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Edison
country: United States
facility: John F. Kennedy Medical Center
state: New Jersey
city: Elizabeth
country: United States
facility: Trinitas Hospital - Jersey Street Campus
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Millville
country: United States
facility: South Jersey Regional Cancer Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Pomona
country: United States
facility: Atlantic City Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Somerville
country: United States
facility: Somerset Medical Center
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Warren
country: United States
facility: Associated Radiologists, P.A.
state: New Jersey
city: Albuquerque
country: United States
facility: Saint Joseph Medical Center
state: New Mexico
city: Albany
country: United States
facility: Cancer Center of Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Albert Einstein Comprehensive Cancer Center
state: New York
city: Brooklyn
country: United States
facility: State University of New York Health Science Center at Brooklyn
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Clifton Springs
country: United States
facility: Finger Lakes Radiation Oncology, P.C.
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center
state: New York
city: Plattsburgh
country: United States
facility: Champlain Valley Physicians Hospital Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Syracuse
country: United States
facility: CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Yonkers
country: United States
facility: Riverhill Radiation Oncology
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Concord
country: United States
facility: Northeast Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University School of Medicine
state: North Carolina
city: Hickory
country: United States
facility: Catawba Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Fargo
country: United States
facility: Meritcare Roger Maris Cancer Center
state: North Dakota
city: Minot
country: United States
facility: Trinity Cancer Care Center
state: North Dakota
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Barrett Cancer Center, The University Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Kettering
country: United States
facility: CCOP - Dayton
state: Ohio
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital Oncology Program
state: Ohio
city: Oklahoma City
country: United States
facility: St. Anthony Hospital
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: St. John Health System
state: Oklahoma
city: Portland
country: United States
facility: CCOP - Columbia River Program
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hospital Regional Cancer Center
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Darby
country: United States
facility: Fitzgerald Mercy Hospital
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Pocono Cancer Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Geisinger Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Veterans Affairs Medical Center - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Mercy Hospital of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Scranton
country: United States
facility: Mercy Hospital Cancer Center - Scranton
state: Pennsylvania
city: Sellersville
country: United States
facility: Grand View Hospital
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Wilkes Barre General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Medical Center/BUSM
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee, Memphis Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Amarillo
country: United States
facility: Harrington Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Julie and Ben Rogers Cancer Institute
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall - 59th Medical Wing
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Pasadena
country: United States
facility: Bayshore Medical Center
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center - Cancer Institute
state: Texas
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Bennington
country: United States
facility: CCOP - Southwestern Vermont Regional Cancer Center
state: Vermont
city: Burlington
country: United States
facility: Vermont Cancer Center
state: Vermont
city: Rutland
country: United States
facility: Green Mountain Oncology Group
state: Vermont
city: Charlottesville
country: United States
facility: Martha Jefferson Hospital
state: Virginia
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Harrisonburg
country: United States
facility: RMH Regional Canter Center
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center, Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Bon-Secours - St. Mary's Hospital
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
city: Wheeling
country: United States
facility: Schiffler Cancer Center
state: West Virginia
city: Green Bay
country: United States
facility: St. Vincent Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundation
state: Wisconsin
city: Madison
country: United States
facility: Southern Wisconsin Radiotherapy Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Community Memorial Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Joseph's Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
city: Racine
country: United States
facility: Southeastern Wisconsin Regional Cancer Center
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. Johns
country: Canada
facility: Newfoundland Cancer Treatment and Research Foundation
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Cancer Care Ontario-Hamilton Regional Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre - General Campus
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre, Sudbury
state: Ontario
city: Thunder Bay
country: Canada
facility: Northwestern Ontario Regional Cancer Centre, Thunder Bay
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Fox Chase Cancer Center
name: Benjamin Movsas, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.