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Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
This study has been completed.
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005087
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy.


Condition Intervention Phase
Head and Neck Cancer
Biological: filgrastim
Drug: cisplatin
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
Detailed Description:

OBJECTIVES:

  • Determine the median, one-year, and long-term (defined as two-year) disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and filgrastim (G-CSF) combined with radiotherapy.
  • Determine the rates of acute and late toxic effects of this regimen in these patients.
  • Determine the pattern of disease progression in patients treated with this regimen.

OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim (G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who initially respond to therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment field) may undergo surgical resection.

Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck

    • More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy
  • Disease must be confined to the head and neck (above the clavicles)
  • No primary SCC of the nasopharynx or salivary gland
  • Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume
  • Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy

    • Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded
  • Measurable disease
  • Ineligible for complete surgical resection
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0 or 1

Life expectancy:

  • No other concurrent illness that would limit survival

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT no greater than 2 times normal*
  • Alkaline phosphatase no greater than 2 times normal*
  • * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer)
  • No other concurrent illness that would impair tolerance to therapy
  • No grade 2 or worse pre-existing peripheral sensory neuropathy
  • No hypersensitivity to E. coli derived products
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior chemotherapy allowed as a component of the primary treatment
  • No prior chemotherapy for recurrent disease
  • At least 6 months since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005087

  Hide Study Locations
Locations
United States, Alabama
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-3657
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
Huntsville Hospital System
Huntsville, Alabama, United States, 35807
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90025-1781
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Huntington Cancer Center
Pasadena, California, United States, 91105
California Cancer Center
Fresno, California, United States, 93729-5100
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
O'Connor Hospital
San Jose, California, United States, 95128
Radiation Medical Group, Inc.
San Diego, California, United States, 92101
Sutter Health West Cancer Research Group
Greenbrae, California, United States, 94904
Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, United States, 91767
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502-1628
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Connecticut
Hospital of St. Raphael
New Haven, Connecticut, United States, 06511
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
Bay Medical Center
Panama City, Florida, United States, 32401
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901-3276
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Florida Radiation Oncology Group
Jacksonville, Florida, United States, 32207
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806-2134
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32308
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31901
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Bloomington Hospital
Bloomington, Indiana, United States, 47402
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Clarian Health Partners Inc.
Indianapolis, Indiana, United States, 46206-1367
Regional Cancer Center
Indianapolis, Indiana, United States, 46219
St. John's Medical Center
Anderson, Indiana, United States, 46016
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Louisville Radiation Oncology
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Anne Arundel Oncology Center
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Henry Ford Hospital
Detroit, Michigan, United States, 48202
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
Hurley Medical Center
Flint, Michigan, United States, 48503
Marquette General Hospital
Marquette, Michigan, United States, 49855
McLaren Regional Cancer Center
Flint, Michigan, United States, 48532-3685
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63108
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
Nebraska Health System
Omaha, Nebraska, United States, 68198-7460
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 38103-2807
Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Associated Radiologists, P.A.
Warren, New Jersey, United States, 07059
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
United States, New Mexico
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
New York Methodist Hospital
Brooklyn, New York, United States, 11215
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Northeast Medical Center
Concord, North Carolina, United States, 28025
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44302
CCOP - Columbus
Columbus, Ohio, United States, 43206
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0502
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73101
St. John Health System
Tulsa, Oklahoma, United States, 74104
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
York Cancer Center
York, Pennsylvania, United States, 17403
United States, Rhode Island
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301-3956
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Bayshore Medical Center
Pasadena, Texas, United States, 77504
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05405-0075
United States, Virginia
Bon Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23226
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
Massey Cancer Center
Richmond, Virginia, United States, 23298-0058
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Deaconess Medical Center
Spokane, Washington, United States, 99204
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
All Saints Cancer Center
Racine, Wisconsin, United States, 53405
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4MI
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Langer CJ, Harris J, Horwitz EM, Nicolaou N, Kies M, Curran W, Wong S, Ang K. Phase II study of low-dose paclitaxel and cisplatin in combination with split-course concomitant twice-daily reirradiation in recurrent squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Protocol 9911. J Clin Oncol. 2007 Oct 20;25(30):4800-5.
Horwitz EM, Harris J, Langer CJ, et al.: Concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): update of RTOG 9911 . [Abstract] J Clin Oncol 23 (Suppl 16): A-5577, 519s, 2005.
Horwitz EM, Harris J, Langer CJ, et al.: Phase II study of paclitaxel and cisplatin in combination with split course concomitant hyperfractioned re-irradiation in patients with recurrent squamous cell cancer of the head and neck : results of RTOG 99-11. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-119, S72, 2005.
Langer CJ, Harris J, Horwitz E, et al.: Phase II trial of concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): results of RTOG 9911. [Abstract] J Clin Oncol 22 (Suppl 14): A-5509, 490s, 2004.

Study ID Numbers: CDR0000067705, RTOG-9911
Study First Received: April 6, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005087     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Cisplatin
Radiation-Sensitizing Agents
Paclitaxel
Head and Neck Neoplasms
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009