Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

November 14, 2015 updated by: Radiation Therapy Oncology Group

Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.

Study Overview

Status

Completed

Conditions

Head and Neck Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck.
Determine the disease-free and overall survival of patients treated with this regimen.
Determine the acute and chronic toxicity of this regimen in these patients.
Determine the patterns of failure in patients treated with this regimen.

OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Center - Calgary
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Newfoundland and Labrador
  - St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
    - Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Cancer Care Ontario-Hamilton Regional Cancer Centre
  - Kingston, Ontario, Canada, K7L 5P9
    - Kingston Regional Cancer Centre
  - London, Ontario, Canada, N6A 4L6
    - Cancer Care Ontario-London Regional Cancer Centre
  - Ottawa, Ontario, Canada, K1H 1C4
    - Ottawa Regional Cancer Centre
  - Sudbury, Ontario, Canada, P3E 5J1
    - Northeastern Ontario Regional Cancer Centre, Sudbury
  - Thunder Bay, Ontario, Canada, P7A 7T1
    - Northwestern Ontario Regional Cancer Centre, Thunder Bay
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto Sunnybrook Regional Cancer Centre
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
- Quebec
  - Fleurimont, Quebec, Canada, J1H 5N4
    - CHUS-Hopital Fleurimont
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University
  - Montreal, Quebec, Canada, H2L 4MI
    - Centre Hospitalier de l'Université de Montréal
  - Quebec City, Quebec, Canada, G1R 2J6
    - Centre Hospitalier Universitaire de Quebec
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Huntsville, Alabama, United States, 35801
    - Comprehensive Cancer Institute of Huntsville
  - Huntsville, Alabama, United States, 35807
    - Huntsville Hospital System
  - Mobile, Alabama, United States, 36688
    - MBCCOP - Gulf Coast
  - Montgomery, Alabama, United States, 36106-3657
    - Alabama Oncology, LLC
  - Tuscaloosa, Alabama, United States, 35401
    - DCH Cancer Treatment Center
- Arizona
  - Phoenix, Arizona, United States, 85013
    - Foundation for Cancer Research and Education
- California
  - Concord, California, United States, 94524-4110
    - Mount Diablo Medical Center
  - Duarte, California, United States, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fresno, California, United States, 93720
    - Saint Agnes Cancer Center
  - Fresno, California, United States, 93729-5100
    - California Cancer Center
  - Greenbrae, California, United States, 94904
    - Sutter Health West Cancer Research Group
  - Loma Linda, California, United States, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, United States, 90822
    - Veterans Affairs Medical Center - Long Beach
  - Los Angeles, California, United States, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Los Angeles, California, United States, 90025-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Oakland, California, United States, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Pasadena, California, United States, 91105
    - Huntington Cancer Center
  - Pomona, California, United States, 91767
    - Robert and Beverly Lewis Family Cancer Care Center
  - Sacramento, California, United States, 95816
    - Radiation Oncology Center - Sacramento
  - San Diego, California, United States, 92101
    - Radiation Medical Group, Inc.
  - San Francisco, California, United States, 94143-0128
    - UCSF Comprehensive Cancer Center
  - San Jose, California, United States, 95128
    - O'Connor Hospital
  - Santa Rosa, California, United States, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base, California, United States, 94535
    - David Grant Medical Center
- Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Cancer Center
  - Denver, Colorado, United States, 80010
    - University of Colorado Cancer Center
  - Grand Junction, Colorado, United States, 81502-1628
    - Saint Mary's Hospital and Medical Center
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - Hospital of St. Raphael
- Delaware
  - Wilmington, Delaware, United States, 19899
    - CCOP - Christiana Care Health Services
- Florida
  - Gainesville, Florida, United States, 32610-0385
    - University of Florida Health Science Center
  - Jacksonville, Florida, United States, 32207
    - Florida Radiation Oncology Group
  - Melbourne, Florida, United States, 32901-3276
    - Health First Holmes Regional Medical Center
  - Miami, Florida, United States, 33136
    - Sylvester Cancer Center, University of Miami
  - Miami, Florida, United States, 33125
    - Veterans Affairs Medical Center - Miami
  - Miami, Florida, United States, 33256-2110
    - Baptist Hospital of Miami
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32806-2134
    - MD Anderson Cancer Center Orlando
  - Panama City, Florida, United States, 32405-4587
    - Gulf Coast Cancer Treatment Center
  - Panama City, Florida, United States, 32401
    - Bay Medical Center
  - Sarasota, Florida, United States, 34233
    - Sarasota Radiation and Medical Oncology Center
  - Tallahassee, Florida, United States, 32308
    - Tallahassee Memorial HealthCare
  - Tampa, Florida, United States, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital - Atlanta
  - Atlanta, Georgia, United States, 30342-1701
    - CCOP - Atlanta Regional
  - Columbus, Georgia, United States, 31901
    - Medical Center/John B. Amos Community Cancer Center
  - Rome, Georgia, United States, 30165
    - Regional Radiation Oncology Center at Rome
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - MBCCOP - Hawaii
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Community Hospital
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - CCOP - Central Illinois
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Park Ridge, Illinois, United States, 60068
    - Lutheran General Cancer Care Center
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
- Indiana
  - Anderson, Indiana, United States, 46016
    - St. John's Medical Center
  - Bloomington, Indiana, United States, 47402
    - Bloomington Hospital
  - Indianapolis, Indiana, United States, 46202
    - Veterans Affairs Medical Center - Indianapolis (Roudebush)
  - Indianapolis, Indiana, United States, 46206-1367
    - Clarian Health Partners Inc.
  - Indianapolis, Indiana, United States, 46219
    - Regional Cancer Center
  - Muncie, Indiana, United States, 47303-3499
    - Ball Memorial Hospital
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
- Iowa
  - Dubuque, Iowa, United States, 52001
    - Wendt Regional Cancer Center of Finley Hospital
- Kentucky
  - Lexington, Kentucky, United States, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
  - Lexington, Kentucky, United States, 40503
    - Central Baptist Hospital
  - Louisville, Kentucky, United States, 40202
    - James Graham Brown Cancer Center
  - Louisville, Kentucky, United States, 40215
    - Louisville Radiation Oncology
  - Madisonville, Kentucky, United States, 42431
    - Merle M. Mahr Cancer Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Medical Center
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70112-2699
    - Tulane University School of Medicine
- Maine
  - Portland, Maine, United States, 04102
    - Maine Medical Center
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Anne Arundel Oncology Center
  - Baltimore, Maryland, United States, 21215
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, United States, 21201
    - Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  - Baltimore, Maryland, United States, 21231
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center and Cancer Center
  - Baltimore, Maryland, United States, 21215-1290
    - Harbor Hospital Center
  - Salisbury, Maryland, United States, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Hyannis, Massachusetts, United States, 02601
    - Cape Cod Hospital
  - Jamaica Plain, Massachusetts, United States, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, United States, 48109-0752
    - University Of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48532-3685
    - McLaren Regional Cancer Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - CCOP - Kalamazoo
  - Marquette, Michigan, United States, 49855
    - Marquette General Hospital
  - Midland, Michigan, United States, 48670
    - MidMichigan Medical Center - Midland
  - Royal Oak, Michigan, United States, 48073-6769
    - CCOP - Beaumont
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital
  - Troy, Michigan, United States, 48098
    - William Beaumont Hospital - Troy
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
- Missouri
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, United States, 63110-0250
    - St. Louis University Health Sciences Center
  - Saint Louis, Missouri, United States, 63108
    - Mallinckrodt Institute of Radiology
  - Springfield, Missouri, United States, 65807
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65807
    - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68114
    - Methodist Hospital Cancer Center - Omaha
  - Omaha, Nebraska, United States, 68198-7460
    - Nebraska Health System
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center
  - Manchester, New Hampshire, United States, 03103
    - Elliot Regional Cancer Center
- New Jersey
  - East Orange, New Jersey, United States, 07019
    - Veterans Affairs Medical Center - East Orange
  - Edison, New Jersey, United States, 08818
    - John F. Kennedy Medical Center
  - Elizabeth, New Jersey, United States, 07201
    - Trinitas Hospital - Jersey Street Campus
  - Long Branch, New Jersey, United States, 07740-6395
    - Monmouth Medical Center
  - Millville, New Jersey, United States, 08332
    - South Jersey Regional Cancer Center
  - Mount Holly, New Jersey, United States, 08060
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
  - New Brunswick, New Jersey, United States, 38103-2807
    - Cancer Institute Of New Jersey
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Pomona, New Jersey, United States, 08240
    - Atlantic City Medical Center
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
  - Trenton, New Jersey, United States, 08629
    - St. Francis Medical Center
  - Warren, New Jersey, United States, 07059
    - Associated Radiologists, P.A.
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Radiation Oncology Associates of Albuquerque
- New York
  - Albany, New York, United States, 12208
    - Cancer Center of Albany Medical Center
  - Brooklyn, New York, United States, 11203
    - State University of New York Health Science Center at Brooklyn
  - Brooklyn, New York, United States, 11215
    - New York Methodist Hospital
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - Clifton Springs, New York, United States, 14432
    - Finger Lakes Radiation Oncology Center
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - New York, New York, United States, 10032
    - Herbert Irving Comprehensive Cancer Center
  - Plattsburgh, New York, United States, 12901
    - Champlain Valley Physicians Hospital Medical Center
  - Poughkeepsie, New York, United States, 12601
    - Vassar Brothers Medical Center
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center
  - Syracuse, New York, United States, 13217
    - CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  - Yonkers, New York, United States, 10701
    - Riverhill Radiation Oncology
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Concord, North Carolina, United States, 28025
    - Northeast Medical Center
  - Greenville, North Carolina, United States, 27858-4354
    - East Carolina University School of Medicine
  - Winston-Salem, North Carolina, United States, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
  - Winston-Salem, North Carolina, United States, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, United States, 44302
    - Akron General Medical Center
  - Akron, Ohio, United States, 44304
    - Akron City Hospital
  - Cincinnati, Ohio, United States, 45219
    - Christ Hospital
  - Cincinnati, Ohio, United States, 45267-0502
    - Barrett Cancer Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44106
    - University Hospitals of Cleveland
  - Cleveland, Ohio, United States, 44106-5065
    - Ireland Cancer Center
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Columbus, Ohio, United States, 43206
    - CCOP - Columbus
  - Dayton, Ohio, United States, 45429
    - CCOP - Dayton
  - Toledo, Ohio, United States, 43623-3456
    - CCOP - Toledo Community Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73101
    - St. Anthony Hospital
  - Tulsa, Oklahoma, United States, 74136
    - CCOP - Oklahoma
  - Tulsa, Oklahoma, United States, 74104
    - St. John Health System
- Oregon
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Program
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18105
    - LeHigh Valley Hospital
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Hospital Cancer Center
  - Danville, Pennsylvania, United States, 17822-2001
    - Geisinger Medical Center
  - Darby, Pennsylvania, United States, 19023
    - Mercy Fitzgerald Hospital
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Memorial Hospital
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Cancer Center
  - Hershey, Pennsylvania, United States, 17033-0850
    - Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Veterans Affairs Medical Center - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107-5541
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19141-3098
    - Albert Einstein Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, United States, 15213-3489
    - University of Pittsburgh Cancer Institute
  - Pittsburgh, Pennsylvania, United States, 15219
    - Mercy Hospital of Pittsburgh
  - Reading, Pennsylvania, United States, 19612-6052
    - Reading Hospital and Medical Center
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital Cancer Center - Scranton
  - Wilkes-Barre, Pennsylvania, United States, 18764
    - Wilkes Barre General Hospital
  - York, Pennsylvania, United States, 17403
    - York Cancer Center
- Rhode Island
  - Providence, Rhode Island, United States, 02908-4735
    - Roger Williams Medical Center/BUSM
- South Carolina
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
- South Dakota
  - Rapid City, South Dakota, United States, 57709
    - Rapid City Regional Hospital
- Tennessee
  - Jackson, Tennessee, United States, 38301-3956
    - Jackson-Madison County General Hospital
  - Memphis, Tennessee, United States, 38103
    - University of Tennessee Cancer Institute
  - Nashville, Tennessee, United States, 37232-5671
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Amarillo, Texas, United States, 79106
    - Harrington Cancer Center
  - Galveston, Texas, United States, 77555-0209
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030-4009
    - University of Texas - MD Anderson Cancer Center
  - Lackland Air Force Base, Texas, United States, 78236-5300
    - Wilford Hall Medical Center
  - Lubbock, Texas, United States, 79410-1894
    - Joe Arrington Cancer Research and Treatment Center
- Utah
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center
  - Salt Lake City, Utah, United States, 84132
    - University of Utah Health Sciences Center
  - Salt Lake City, Utah, United States, 84143
    - Latter Day Saints Hospital
- Vermont
  - Burlington, Vermont, United States, 05405-0075
    - Vermont Cancer Center
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Cancer Center at the University of Virginia
  - Harrisonburg, Virginia, United States, 22801
    - RMH Regional Cancer Center
  - Portsmouth, Virginia, United States, 23708-2197
    - Naval Medical Center, Portsmouth
  - Richmond, Virginia, United States, 23226
    - Bon Secours - St. Mary's Hospital
  - Richmond, Virginia, United States, 23298-0058
    - Massey Cancer Center
- Washington
  - Seattle, Washington, United States, 98111
    - Virginia Mason Medical Center
  - Spokane, Washington, United States, 99204
    - Deaconess Medical Center
  - Yakima, Washington, United States, 98902
    - Yakima Valley Memorial Hospital
- West Virginia
  - Wheeling, West Virginia, United States, 26003
    - Schiffler Cancer Center
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Foundation
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Comprehensive Cancer Center
  - Madison, Wisconsin, United States, 53713
    - Southern Wisconsin Radiotherapy Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Menomonee Falls, Wisconsin, United States, 53051
    - Community Memorial Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53211
    - Columbia Hospital
  - Milwaukee, Wisconsin, United States, 53215
    - St. Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53295
    - Veterans Affairs Medical Center - Milwaukee (Zablocki)
  - Racine, Wisconsin, United States, 53405
    - All Saints Cancer Center
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Histologically proven stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
- Gross total resection completed or planned
  - No less than gross total resection
  - No disease requiring staging surgery
Prior gross total resection completed with one or more of the following risk factors:
- Histologically proven multiple lymph node metastases
- At least 1 lymph node with extracapsular extension of tumor
- Positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection OR
Gross total resection planned within 14 days of study enrollment with anticipated need for postoperative radiotherapy for one of the following:
- Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm
- Single clinically/radiologically evident lymph node of at least 3 cm
- Histologically proven lymph node metastases
No T3, N0 glottic cancer
No nasopharyngeal or paranasal sinus carcinoma
No distant metastases

PATIENT CHARACTERISTICS:

Age:

21 and over

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

White blood cell (WBC) at least 3,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 1.5 times ULN

Renal:

Creatinine no greater than 1.5 ULN

Cardiovascular:

No unstable angina
No myocardial infarction within the past 6 months unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty
No uncontrolled arrhythmia
No second or third degree heart block or other clinically significant conduction system abnormality unless pacemaker is in place

Pulmonary:

No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No pre-existing grade 2 or greater peripheral neurotoxicity
No other prior malignancy within the past 3 years except low-risk nonmelanomatous skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low to moderate grade prostate cancer
No significant wound infection
No fistula
No major wound dehiscence
Nutritional status adequate

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Concurrent colony-stimulating factors for neutropenic fever during study chemoradiotherapy allowed

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior radiotherapy to head and neck

Surgery:

See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery, chemotherapy and radiation therapy Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.	Radiation: radiation therapy Drug: cisplatin Procedure: conventional surgery Drug: paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient tolerance of the treatment regimen Time Frame: From registration to end of treatment	From registration to end of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of grade 5 and acute non-hematologic grade 4 toxicity Time Frame: From start of induction chemotherapy to 90 days after start of radiation therapy	From start of induction chemotherapy to 90 days after start of radiation therapy
Frequency of other acute and late toxicity Time Frame: From start of induction chemotherapy to last follow-up	From start of induction chemotherapy to last follow-up
Local-regional control Time Frame: From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.	From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.
Disease-free survival Time Frame: From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years.	From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years.
Overall survival Time Frame: From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.	From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Randal S. Weber, MD, Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Rosenthal DI, Harris J, Forastiere AA, Weber RS, Ridge JA, Myers JN, Garden AS, Kuettel MR, Sidhu K, Schultz CJ, Trotti A, Ang KK. Early postoperative paclitaxel followed by concurrent paclitaxel and cisplatin with radiation therapy for patients with resected high-risk head and neck squamous cell carcinoma: report of the phase II trial RTOG 0024. J Clin Oncol. 2009 Oct 1;27(28):4727-32. doi: 10.1200/JCO.2008.21.4197. Epub 2009 Aug 31.
Rosenthal DJ, Harris J, Forastiere AA, et al.: Early postoperative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy (RT) (phase II trial RTOG H-0024) is well tolerated for patients with resected, high-risk squamous carcinoma of the head and neck (HNSCC). [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-1111, S322, 2004.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 3, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 14, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RTOG-H-0024
CDR0000068469

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers