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Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer

2015년 11월 14일 업데이트: Radiation Therapy Oncology Group

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

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

105

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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
  • Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Radiation (BID) and chemotherapy
Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13.
방사능: 방사선 요법
의약품: 시스플라틴
절차: 기존 수술
의약품: 파클리탁셀
생물학적: 필그라스팀

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Overall Survival
기간: From registration to 1 year
From registration to 1 year

2차 결과 측정

결과 측정
기간
Disease-free Survival
기간: From registration to 1 year
From registration to 1 year
Grade 4-5 toxicity
기간: From one year after the start of radiation therapy to last follow-up.
From one year after the start of radiation therapy to last follow-up.
Pattern of failure (local-regional, distant, new primary, death)
기간: From registration to last follow-up.
From registration to last follow-up.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Radiation Therapy Oncology Group

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Corey J. Langer, MD, Fox Chase Cancer Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2000년 3월 1일

기본 완료 (실제)

2004년 11월 1일

연구 완료 (실제)

2013년 11월 1일

연구 등록 날짜

최초 제출

2000년 4월 6일

QC 기준을 충족하는 최초 제출

2003년 1월 26일

처음 게시됨 (추정)

2003년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 11월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 11월 14일

마지막으로 확인됨

2015년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RTOG-9911
  • CDR0000067705

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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