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A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD


OBJECTIVES:

- Compare the local response rate in patients with stage II invasive squamous cell
carcinoma of the true vocal cord treated with hyperfractionation vs conventional
fractionation radiotherapy.

- Compare the acute and late toxic effects of these regimens in this patient population.

- Compare the overall and disease-free survival patterns in this patient population
treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs
T2b). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by
boost radiotherapy 5 days a week for 2 weeks.

- Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks
followed by boost radiotherapy 5 days a week for 1.6 weeks.

Patients with biopsy-proven persistent disease at least 6 weeks after completion of
radiotherapy undergo salvage surgery with neck dissection (at the discretion of the
surgeon).

Patients are followed at 4 weeks, every 3 months for 1 year, every 4 months for 1 year,
every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 3.2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven invasive squamous cell carcinoma of the true vocal cord

- Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the
epicenter) with extension to adjacent areas

- No verrucal carcinoma or adenocarcinoma

- No extension to pre-epiglottic space or pyriform sinus

- No fixed cord or cartilage invasion

- No evidence of adenopathy, including any of the following:

- Nodes larger than 1 cm by radiography

- Nodes containing a low central density consistent with necrosis by radiography

- Clinically palpable nodes larger than 1 cm and firm in consistency

- No recurrent or persistent disease

- No evidence or suspicion of distant metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No other malignancy within the past 5 years except nonmelanomatous skin cancer

- Not pregnant or nursing

- 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 mid-neck or larynx

Surgery:

- No prior complete stripping or laser excision of all gross disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Andy M. Trotti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000064597

NCT ID:

NCT00002727

Start Date:

April 1996

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage II squamous cell carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Hurley Medical CenterFlint, Michigan  48503
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Bloomington HospitalBloomington, Indiana  47402
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - OchsnerNew Orleans, Louisiana  70121
Rapid City Regional HospitalRapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Henry Ford HospitalDetroit, Michigan  48202
Marshfield ClinicMarshfield, Wisconsin  54449
Huntsville Hospital SystemHuntsville, Alabama  35801
Alabama Oncology, LLCMontgomery, Alabama  36106-2801
Mount Diablo Medical CenterConcord, California  94524-4110
California Cancer CenterFresno, California  93720
Saint Agnes Cancer CenterFresno, California  93720
Loma Linda University Medical CenterLoma Linda, California  92354
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Radiation Oncology Center - SacramentoSacramento, California  95816
O'Connor HospitalSan Jose, California  95128
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
University of Florida Health Science CenterGainesville, Florida  32610-0296
Baptist Hospital of MiamiMiami, Florida  33176-2197
Florida Radiation Oncology GroupOrange Park, Florida  32073
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
Sarasota Radiation and Medical Oncology CenterSarasota, Florida  34233
Medical Center/John B. Amos Community Cancer CenterColumbus, Georgia  31902
Northwest Community HospitalArlington Heights, Illinois  60005
Northwestern Memorial HospitalChicago, Illinois  60611
Ingalls Memorial HospitalHarvey, Illinois  60426
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Central IllinoisSpringfield, Illinois  62526
St. John's Medical CenterAnderson, Indiana  46016
Ball Memorial HospitalMuncie, Indiana  47303-3499
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Louisville Radiation OncologyLouisville, Kentucky  40215
Merle M. Mahr Cancer CenterMadisonville, Kentucky  42431
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Tulane University School of MedicineNew Orleans, Louisiana  70112
Maine Medical CenterPortland, Maine  04102
Anne Arundel Oncology CenterAnnapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Harbor Hospital CenterBaltimore, Maryland  21225
Cape Cod HospitalHyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer CenterFlint, Michigan  48432
Marquette General HospitalMarquette, Michigan  49855
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Elliot Regional Cancer CenterManchester, New Hampshire  03103
John F. Kennedy Medical CenterEdison, New Jersey  08818
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
New York Methodist HospitalBrooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Northeast Medical CenterConcord, North Carolina  28025
Akron General Medical CenterAkron, Ohio  44302
Christ HospitalCincinnati, Ohio  45219
University Hospitals of ClevelandCleveland, Ohio  44106
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Veterans Affairs Medical Center - PhiladelphiaPhiladelphia, Pennsylvania  19104
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Wilkes Barre General HospitalWilkes-Barre, Pennsylvania  18764
Roger Williams Medical Center/BUSMProvidence, Rhode Island  02908-4735
CCOP - GreenvilleGreenville, South Carolina  29615
Jackson-Madison County General HospitalJackson, Tennessee  38301
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Bayshore Medical CenterPasadena, Texas  77504
Dixie Regional Medical CenterSaint George, Utah  84770
Green Mountain Oncology GroupRutland, Vermont  05701
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
Virginia Mason Medical CenterSeattle, Washington  98111
Deaconess Medical CenterSpokane, Washington  99210-0248
Yakima Valley Memorial HospitalYakima, Washington  98902
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical FoundationLa Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Southern Wisconsin Radiotherapy CenterMadison, Wisconsin  53713
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Columbia HospitalMilwaukee, Wisconsin  53211
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
CCOP - OklahomaTulsa, Oklahoma  74136
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Bay Medical CenterPanama City, Florida  32401
Tallahassee Memorial HealthcareTallahassee, Florida  32308
Peninsula Regional Medical CenterSalisbury, Maryland  21801
MidMichigan Medical Center - MidlandMidland, Michigan  48670
William Beaumont HospitalRoyal Oak, Michigan  48073
Nebraska Health SystemOmaha, Nebraska  68105-1018
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Atlantic City Medical CenterPomona, New Jersey  08240
Associated Radiologists, P.A.Warren, New Jersey  07059
St. Anthony HospitalOklahoma City, Oklahoma  73101
St. John Health SystemTulsa, Oklahoma  74104
University of Utah Health Sciences CenterSalt Lake City, Utah  84132
Schiffler Cancer CenterWheeling, West Virginia  26003
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
James P. Wilmot Cancer CenterRochester, New York  14642
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
DCH Cancer Treatment CenterTuscaloosa, Alabama  35401
Sutter Health West Cancer Research GroupGreenbrae, California  94904
Huntington Cancer CenterPasadena, California  91105
Robert and Beverly Lewis Family Cancer Care CenterPomona, California  91767
Radiation Medical Group, IncorporatedSan Diego, California  92101
Saint Mary's Hospital and Medical CenterGrand Junction, Colorado  81502-1628
Hospital of St. RaphaelNew Haven, Connecticut  06511
Holmes Regional Medical CenterMelbourne, Florida  32901-3276
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Clarian Health Partners Inc.Indianapolis, Indiana  46206-1367
Community Regional Cancer CareIndianapolis, Indiana  46219
Central Baptist HospitalLexington, Kentucky  40503
William Beaumont Hospital - TroyTroy, Michigan  48098
Methodist Hospital Cancer Center - OmahaOmaha, Nebraska  68114
Fox Chase Virtua Health Cancer Program at Virtua Memorial HospitalMount Holly, New Jersey  08060
Valley HospitalRidgewood, New Jersey  07450
Radiation Oncology Associates of AlbuquerqueAlbuquerque, New Mexico  87109
Finger Lakes Radiation Oncology CenterClifton Springs, New York  14432
Vassar Brothers Medical CenterPoughkeepsie, New York  12601
Riverhill Radiation OncologyYonkers, New York  10701
Trinity Cancer Care CenterMinot, North Dakota  58701
Barrett Cancer CenterCincinnati, Ohio  45267-0502
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
Pocono Cancer CenterEast Stroudsburg, Pennsylvania  18301
York Cancer CenterYork, Pennsylvania  17403
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Latter Day Saints HospitalSalt Lake City, Utah  84143
RMH Regional Cancer CenterHarrisonburg, Virginia  22801
Bon Secours - St. Mary's HospitalRichmond, Virginia  23226
All Saints Cancer CenterRacine, Wisconsin  53405
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188