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A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas


OBJECTIVES:

Primary

- Compare overall survival of patients with stage III or IV squamous cell carcinoma of
the head and neck treated with conventional vs accelerated radiotherapy and concurrent
cisplatin with or without surgical resection.

Secondary

- Compare local-regional control of disease and disease-free rates in patients treated
with these regimens.

- Compare the acute and late toxicity of these regimens in these patients.

- Compare quality of life, perception of side effects, and performance status of patients
treated with these regimens.

- Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions
are independent prognostic markers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod
performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks.
Patients also receive cisplatin IV on days 1, 22, and 43.

- Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5
weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive
cisplatin IV on days 1 and 22.

Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy
undergo surgical resection of the primary tumor.

Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3
and 12 months, and then annually for 4 years.

Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years,
and then annually thereafter.

PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx, or larynx

- Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)

- No metastases below the clavicle or more distant by clinical exam or radiology

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2
times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 50 mL/min

- Calcium normal

Cardiovascular

- No symptomatic coronary artery disease (angina)

- No myocardial infarction within the past 6 months

Other

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

- No simultaneous primary tumors

- 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 radiotherapy to the head and neck except radioactive iodine therapy

Surgery

- No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal
sampling of neck disease

- No radical or modified neck dissection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.

Safety Issue:

No

Principal Investigator

K. Kian Ang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

RTOG 0129

NCT ID:

NCT00047008

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
St. Rita's Medical CenterLima, Ohio  45801
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Rapid City Regional HospitalRapid City, South Dakota  57709
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
Northwest Community HospitalArlington Heights, Illinois  60005
Memorial Hospital of South BendSouth Bend, Indiana  46601
Cape Cod HospitalHyannis, Massachusetts  02601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Community Medical CenterToms River, New Jersey  08755
New York Methodist HospitalBrooklyn, New York  11215-3609
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of California Davis Cancer CenterSacramento, California  95817
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Trinity Cancer Care CenterMinot, North Dakota  58701
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
21st Century Oncology - Fort MyersFort Myers, Florida  33901-8082
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Summit Medical CenterOakland, California  94609
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Elkhart General HospitalElkhart, Indiana  46515
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Saint Rose HospitalHayward, California  94545
J.C. Robinson, M.D. Regional Cancer CenterSan Pablo, California  94806
Beebe Medical CenterLewes, Delaware  19958
St. Francis HospitalWilmington, Delaware  19805
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Danville Regional Medical CenterDanville, Virginia  24541
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
Cancer Center at Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70140-1015
DeCesaris Cancer Institute at Anne Arundel Medical CenterAnnapolis, Maryland  21401
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Valley Memorial HospitalLivermore, California  94550
Providence Holy Cross Cancer CenterMission Hills, California  91346-9600
Highland General HospitalOakland, California  94602
Pomona Valley Hospital Medical CenterPomona, California  91767
Radiological Associates of Sacramento Medical Group, Inc.Sacramento, California  95815
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Northeast Georgia Medical CenterGainesville, Georgia  30501
Creticos Cancer Center at Advocate Illinois Masonic Medical CenterChicago, Illinois  60657
Cancer Care Center at Advocate Good Samaritan HospitalDowners Grove, Illinois  60515
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Saint Joseph Regional Medical Center - Plymouth CampusPlymouth, Indiana  46544
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
Cancer Treatment Center at the Medical Center - Bowling GreenBowling Green, Kentucky  42101
Tulane Cancer CenterNew Orleans, Louisiana  70112
Hudner Oncology Center at Saint Anne's HospitalFall River, Massachusetts  02721
South Suburban Oncology CenterQuincy, Massachusetts  02169
Great Lakes Cancer Institute at McLaren Regional Medical CenterFlint, Michigan  48532
Washoe Cancer Services at Washoe Medical Center - RenoReno, Nevada  89502
South Jersey Healthcare Regional Cancer CenterMillville, New Jersey  08332
Randolph HospitalAsheboro, North Carolina  27203
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial HospitalEden, North Carolina  27288
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Akron City Hospital at Summa Health SystemAkron, Ohio  44304
Miami Valley HospitalDayton, Ohio  45409
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
LaFortune Cancer Center at St. John Health SystemTulsa, Oklahoma  74104
Cancer Center at Paoli Memorial HospitalPaoli, Pennsylvania  19301
St. Mary's Hospital Medical CenterGreen Bay, Wisconsin  54303
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial HospitalInglewood, California  90301
St. John's Cancer Center at St. John's Medical CenterAnderson, Indiana  46016
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Rappahannock General HospitalKilmarnock, Virginia  22482
Virginia G. Piper Cancer Center at Scottsdale Healthcare - OsbornScottsdale, Arizona  85251
Alexian Brothers Cancer Care CenterElk Grove Village, Illinois  60007
John B. Amos Community Cancer CenterColumbus, Georgia  31902
Washington Hematology - Oncology SpecialistsYakima, Washington  98902
North Star Lodge Cancer CenterYakima, Washington  98902
Mount Sinai Hospital Medical CenterChicago, Illinois  60608
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Scottsdale Healthcare - SheaScottsdale, Arizona  85260
Shands Cancer Center at the University of Florida - JacksonvilleGainesville, Florida  32610
Georgia Cancer Center for Excellence at Grady Memorial HospitalAtlanta, Georgia  30303
New Orleans Cancer Institute at Memorial Medical CenterNew Orleans, Louisiana  70115
Cancer Institute of Cape GirardeauCape Girardeau, Missouri  63703
Community Memorial Health CenterSouth Hill, Virginia  23970-0090
Holy Family Memorial Medical CenterManitowoc, Wisconsin  54221
St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee CampusMilwaukee, Wisconsin  53211