Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

743

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

June 30, 2010

Study Completion Date

May 20, 2022

Conditions
Head and Neck Cancer
Interventions
DRUG

cisplatin

100 mg/m\^2 intravenously on days 1, 22

RADIATION

Standard fractionation RT

Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy.

RADIATION

Accelerated fractionation radiation therapy

Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks.

PROCEDURE

Conventional surgery for select patients

"Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer.~A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made."

Trial Locations (195)

11030

CCOP - North Shore University Hospital, Manhasset

11215

New York Methodist Hospital, Brooklyn

12901

Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center, Plattsburgh

13210

SUNY Upstate Medical University Hospital, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

15219

Mercy Hospital of Pittsburgh, Pittsburgh

18501

Mercy Hospital Cancer Center - Scranton, Scranton

19001

Abington Memorial Hospital, Abington

19010

Bryn Mawr Hospital, Bryn Mawr

19096

CCOP - MainLine Health, Wynnewood

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19107

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

19141

Albert Einstein Cancer Center, Philadelphia

19301

Cancer Center at Paoli Memorial Hospital, Paoli

19718

CCOP - Christiana Care Health Services, Newark

19805

St. Francis Hospital, Wilmington

19958

Beebe Medical Center, Lewes

21401

DeCesaris Cancer Institute at Anne Arundel Medical Center, Annapolis

21921

Union Hospital Cancer Center at Union Hospital, Elkton

22482

Rappahannock General Hospital, Kilmarnock

23249

Veterans Affairs Medical Center - Richmond, Richmond

24541

Danville Regional Medical Center, Danville

26003

Schiffler Cancer Center at Wheeling Hospital, Wheeling

27157

Comprehensive Cancer Center at Wake Forest University, Winston-Salem

27203

Randolph Hospital, Asheboro

27288

John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital, Eden

27320

Annie Penn Cancer Center, Reidsville

27401

Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro

27534

Wayne Memorial Hospital, Incorporated, Goldsboro

Wayne Radiation Oncology, Goldsboro

27893

Wilson Medical Center, Wilson

28139

Rutherford Hospital, Rutherfordton

29303

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

29304

CCOP - Upstate Carolina, Spartanburg

29601

Bon Secours St. Francis Health System, Greenville

29605

Greenville Hospital System Cancer Center, Greenville

29615

CCOP - Greenville, Greenville

29621

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson

30303

Georgia Cancer Center for Excellence at Grady Memorial Hospital, Atlanta

30322

Emory University Hospital - Atlanta, Atlanta

30501

Northeast Georgia Medical Center, Gainesville

31403

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah

31904

John B. Amos Community Cancer Center, Columbus

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

32209

University of Florida Shands Cancer Center, Jacksonville

32405

Gulf Coast Cancer Treatment Center, Panama City

32610

Shands Cancer Center at the University of Florida - Jacksonville, Gainesville

33021

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood

33140

CCOP - Mount Sinai Medical Center, Miami Beach

33308

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale

33458

Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter

33612

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa

33901

21st Century Oncology - Fort Myers, Fort Myers

35294

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham

36607

Mobile Infirmary Medical Center, Mobile

37232

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville

40202

James Graham Brown Cancer Center at University of Louisville, Louisville

40536

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington

42101

Cancer Treatment Center at the Medical Center - Bowling Green, Bowling Green

44304

Akron City Hospital at Summa Health System, Akron

44307

McDowell Cancer Center at Akron General Medical Center, Akron

44460

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem

44691

Cancer Treatment Center, Wooster

45044

Middletown Regional Hospital, Middletown

45373

UVMC Cancer Care Center at Upper Valley Medical Center, Troy

45385

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia

45405

Grandview Hospital, Dayton

45406

Good Samaritan Hospital, Dayton

45409

Miami Valley Hospital, Dayton

45415

Samaritan North Cancer Care Center, Dayton

45428

Veterans Affairs Medical Center - Dayton, Dayton

45429

CCOP - Dayton, Dayton

Charles F. Kettering Memorial Hospital, Kettering

45801

St. Rita's Medical Center, Lima

46016

St. John's Cancer Center at St. John's Medical Center, Anderson

46107

St. Francis Hospital and Health Centers, Beech Grove

46202

Indiana University Cancer Center, Indianapolis

46350

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte

46515

Elkhart General Hospital, Elkhart

46544

Saint Joseph Regional Medical Center - Plymouth Campus, Plymouth

46601

CCOP - Northern Indiana CR Consortium, South Bend

Memorial Hospital of South Bend, South Bend

48100

CCOP - Michigan Cancer Research Consortium, Ann Arbor

48123

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit

48502

Hurley Medical Center, Flint

48532

Genesys Hurley Cancer Institute, Flint

Great Lakes Cancer Institute at McLaren Regional Medical Center, Flint

48601

Seton Cancer Institute - Saginaw, Saginaw

48903

St. John Macomb Hospital, Warren

49001

Borgess Medical Center, Kalamazoo

CCOP - Kalamazoo, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

52001

Wendt Regional Cancer Center at Finley Hospital, Dubuque

53051

Community Memorial Hospital, Menomonee Falls

53188

Waukesha Memorial Hospital Regional Cancer Center, Waukesha

53211

St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus, Milwaukee

53226

Medical College of Wisconsin Cancer Center, Milwaukee

53295

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee

53405

All Saints Cancer Center at All Saints Healthcare, Racine

53792

University of Wisconsin Comprehensive Cancer Center, Madison

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54221

Holy Family Memorial Medical Center, Manitowoc

54301

St. Vincent Hospital, Green Bay

54303

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay

St. Mary's Hospital Medical Center, Green Bay

54601

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse

55905

Mayo Clinic Cancer Center, Rochester

57701

Rapid City Regional Hospital, Rapid City

58701

Trinity Cancer Care Center, Minot

60005

Northwest Community Hospital, Arlington Heights

60007

Alexian Brothers Cancer Care Center, Elk Grove Village

60426

Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey

60515

Cancer Care Center at Advocate Good Samaritan Hospital, Downers Grove

60608

Mount Sinai Hospital Medical Center, Chicago

60611

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

60657

Creticos Cancer Center at Advocate Illinois Masonic Medical Center, Chicago

63110

Saint Louis University Cancer Center, St Louis

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis

63703

Cancer Institute of Cape Girardeau, Cape Girardeau

64131

CCOP - Kansas City, Kansas City

65203

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia

65802

CCOP - Cancer Research for the Ozarks, Springfield

65804

St. John's Regional Health Center, Springfield

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

68114

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha

70112

Cancer Center at Medical Center of Louisiana - New Orleans, New Orleans

MBCCOP - LSU Health Sciences Center, New Orleans

Tulane Cancer Center, New Orleans

70115

New Orleans Cancer Institute at Memorial Medical Center, New Orleans

70806

Baton Rouge General Regional Cancer Center, Baton Rouge

70809

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge

74104

LaFortune Cancer Center at St. John Health System, Tulsa

74136

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa

77030

M.D. Anderson Cancer Center at University of Texas, Houston

78234

Brooke Army Medical Center, Fort Sam Houston

78236

Wilford Hall Medical Center, Lackland Air Force Base

79106

Harrington Cancer Center, Amarillo

80909

Memorial Hospital Cancer Center, Colorado Springs

83706

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

84107

Cottonwood Hospital Medical Center, Murray

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

84403

McKay-Dee Hospital Center, Ogden

84603

Utah Valley Regional Medical Center - Provo, Provo

84770

Dixie Regional Medical Center, St. George

85013

Foundation for Cancer Research and Education, Phoenix

85259

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale

85260

Scottsdale Healthcare - Shea, Scottsdale

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn, Scottsdale

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas

89502

Washoe Cancer Services at Washoe Medical Center - Reno, Reno

90301

Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital, Inglewood

91505

Providence Saint Joseph Medical Center - Burbank, Burbank

91767

Pomona Valley Hospital Medical Center, Pomona

92134

Naval Medical Center - San Diego, San Diego

92354

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda

94545

Saint Rose Hospital, Hayward

94550

Valley Memorial Hospital, Livermore

94602

Highland General Hospital, Oakland

94609

CCOP - Bay Area Tumor Institute, Oakland

Summit Medical Center, Oakland

94806

J.C. Robinson, M.D. Regional Cancer Center, San Pablo

95815

Radiological Associates of Sacramento Medical Group, Inc., Sacramento

95817

University of California Davis Cancer Center, Sacramento

98902

North Star Lodge Cancer Center, Yakima

Washington Hematology - Oncology Specialists, Yakima

90033-0804

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

91346-9600

Providence Holy Cross Cancer Center, Mission Hills

80217-3364

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver

02114

Massachusetts General Hospital Cancer Center, Boston

02118

Cancer Research Center at Boston Medical Center, Boston

02721

Hudner Oncology Center at Saint Anne's Hospital, Fall River

02601

Cape Cod Hospital, Hyannis

02169

South Suburban Oncology Center, Quincy

48106-0995

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

03756

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

08103

Cancer Institute of New Jersey at the Cooper University Hospital, Camden

07740

Monmouth Medical Center, Long Branch

08332

South Jersey Healthcare Regional Cancer Center, Millville

08060

Fox Chase Virtua Health Cancer Program - Marlton, Mount Holly

08755

Community Medical Center, Toms River

44710-1799

Aultman Hospital Cancer Center at Aultman Health Foundation, Canton

17033-0850

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey

19111-2497

Fox Chase Cancer Center, Philadelphia

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

23298-0037

Massey Cancer Center at Virginia Commonwealth University, Richmond

23970-0090

Community Memorial Health Center, South Hill

54301-3526

Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay

53066-3896

Oconomowoc Memorial Hospital, Oconomowoc

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK

NCT00047008 - Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer | Biotech Hunter | Biotech Hunter