Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
2018年11月15日 更新者：Radiation Therapy Oncology Group
A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in 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. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin.
Secondary
- Compare the safety and efficacy of these regimens in these patients.
- Compare locoregional control and overall survival rates in patients treated with these regimens.
- Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1), risk category (positive margins vs high risk [i.e., ≥ 2 positive nodes or extracapsular nodal extension]) and use of intensity-modulated radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5 days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).
- Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7).
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within approximately 29 months.
研究の種類
介入
入学 (実際)
238
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham Comprehensive Cancer Center
-
Mobile、Alabama、アメリカ、36652-2144
- Mobile Infirmary Medical Center
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85013
- Arizona Oncology Services Foundation
-
Scottsdale、Arizona、アメリカ、85259-5499
- Mayo Clinic Scottsdale
-
Scottsdale、Arizona、アメリカ、85260
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
-
Scottsdale、Arizona、アメリカ、85251
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
-
-
California
-
Auburn、California、アメリカ、95603
- Auburn Radiation Oncology
-
Burbank、California、アメリカ、91505
- Providence Saint Joseph Medical Center - Burbank
-
Cameron Park、California、アメリカ、95682
- Radiation Oncology Centers - Cameron Park
-
Carmichael、California、アメリカ、95608
- Mercy Cancer Center at Mercy San Juan Medical Center
-
Loma Linda、California、アメリカ、92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
-
Mission Hills、California、アメリカ、91346-9600
- Providence Holy Cross Cancer Center
-
Oakland、California、アメリカ、94609
- CCOP - Bay Area Tumor Institute
-
Roseville、California、アメリカ、95661
- Radiation Oncology Center - Roseville
-
Sacramento、California、アメリカ、95815
- Radiological Associates of Sacramento Medical Group, Incorporated
-
Sacramento、California、アメリカ、95819
- Mercy General Hospital
-
Sacramento、California、アメリカ、95817
- University of California Davis Cancer Center
-
Torrance、California、アメリカ、90509
- Torrance Memorial Medical Center
-
Vacaville、California、アメリカ、95687
- Solano Radiation Oncology Center
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06511
- Hospital of Saint Raphael
-
-
Delaware
-
Newark、Delaware、アメリカ、19713
- CCOP - Christiana Care Health Services
-
-
Florida
-
Boca Raton、Florida、アメリカ、33486
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
-
Fort Lauderdale、Florida、アメリカ、33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
-
Jacksonville、Florida、アメリカ、32224
- Mayo Clinic - Jacksonville
-
Jacksonville、Florida、アメリカ、32207
- Baptist Cancer Institute - Jacksonville
-
Jupiter、Florida、アメリカ、33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
-
Miami、Florida、アメリカ、33136
- University of Miami Sylvester Comprehensive Cancer Center
-
Miami Beach、Florida、アメリカ、33140
- CCOP - Mount Sinai Medical Center
-
Orlando、Florida、アメリカ、32806
- M.D. Anderson Cancer Center Orlando
-
Tallahassee、Florida、アメリカ、32308
- Tallahassee Memorial Hospital
-
Tampa、Florida、アメリカ、33612-9497
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
-
-
Georgia
-
Columbus、Georgia、アメリカ、31904
- John B. Amos Cancer Center
-
Gainesville、Georgia、アメリカ、30501
- Northeast Georgia Medical Center
-
Savannah、Georgia、アメリカ、31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
-
Illinois
-
Alton、Illinois、アメリカ、62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
-
Harvey、Illinois、アメリカ、60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
-
Maywood、Illinois、アメリカ、60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
-
Mount Vernon、Illinois、アメリカ、62864
- Good Samaritan Regional Health Center
-
Springfield、Illinois、アメリカ、62702
- Cancer Institute at St. John's Hospital
-
-
Indiana
-
Elkhart、Indiana、アメリカ、46515
- Elkhart General Hospital
-
La Porte、Indiana、アメリカ、46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
-
South Bend、Indiana、アメリカ、46601
- Memorial Hospital of South Bend
-
South Bend、Indiana、アメリカ、46601
- CCOP - Northern Indiana CR Consortium
-
-
Iowa
-
Dubuque、Iowa、アメリカ、52001
- Wendt Regional Cancer Center at Finley Hospital
-
-
Kentucky
-
Lexington、Kentucky、アメリカ、40536-0293
- Markey Cancer Center at University of Kentucky Chandler Medical Center
-
Lexington、Kentucky、アメリカ、40504
- John D. Cronin Cancer Center
-
-
Louisiana
-
Alexandria、Louisiana、アメリカ、71315-3198
- Tulane Cancer Center
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital Cancer Center
-
Boston、Massachusetts、アメリカ、02118
- Cancer Research Center at Boston Medical Center
-
Boston、Massachusetts、アメリカ、02115
- Dana-Farber/Brigham and Women's Cancer Center
-
Fall River、Massachusetts、アメリカ、02721
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
-
Detroit、Michigan、アメリカ、48202
- Josephine Ford Cancer Center at Henry Ford Hospital
-
Flint、Michigan、アメリカ、48503
- Hurley Medical Center
-
Flint、Michigan、アメリカ、48503
- Genesys Hurley Cancer Institute
-
Grand Rapids、Michigan、アメリカ、49503
- CCOP - Grand Rapids
-
Grand Rapids、Michigan、アメリカ、49503
- Lacks Cancer Center at Saint Mary's Health Care
-
Kalamazoo、Michigan、アメリカ、49007
- Bronson Methodist Hospital
-
Kalamazoo、Michigan、アメリカ、49001
- Borgess Medical Center
-
Kalamazoo、Michigan、アメリカ、49007-3731
- West Michigan Cancer Center
-
Marquette、Michigan、アメリカ、49855
- Upper Michigan Cancer Center at Marquette General Hospital
-
Saint Joseph、Michigan、アメリカ、49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
-
-
Minnesota
-
Burnsville、Minnesota、アメリカ、55337
- Fairview Ridges Hospital
-
Coon Rapids、Minnesota、アメリカ、55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Edina、Minnesota、アメリカ、55435
- Fairview Southdale Hospital
-
Fridley、Minnesota、アメリカ、55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota Medical Center & Children's Hospital - Fairview
-
Minneapolis、Minnesota、アメリカ、55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
-
Robbinsdale、Minnesota、アメリカ、55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
-
Saint Cloud、Minnesota、アメリカ、56303
- CentraCare Clinic - River Campus
-
Saint Cloud、Minnesota、アメリカ、56303
- Coborn Cancer Center
-
Saint Louis Park、Minnesota、アメリカ、55416
- CCOP - Metro-Minnesota
-
Saint Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Health Services
-
Saint Paul、Minnesota、アメリカ、55102
- United Hospital
-
Waconia、Minnesota、アメリカ、55387
- Ridgeview Medical Center
-
-
Mississippi
-
Pascagoula、Mississippi、アメリカ、39581
- Regional Cancer Center at Singing River Hospital
-
-
Missouri
-
Cape Girardeau、Missouri、アメリカ、63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
-
Cape Girardeau、Missouri、アメリカ、63701
- Saint Francis Medical Center
-
Kansas City、Missouri、アメリカ、64131
- CCOP - Kansas City
-
Saint Louis、Missouri、アメリカ、63141
- CCOP - St. Louis-Cape Girardeau
-
Saint Louis、Missouri、アメリカ、63141
- David C. Pratt Cancer Center at St. John's Mercy
-
Saint Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish Hospital
-
Springfield、Missouri、アメリカ、65804
- St. John's Regional Health Center
-
Springfield、Missouri、アメリカ、65807
- Hulston Cancer Center at Cox Medical Center South
-
-
Nebraska
-
Kearney、Nebraska、アメリカ、68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
-
Omaha、Nebraska、アメリカ、68114
- Methodist Cancer Center at Methodist Hospital - Omaha
-
-
New Hampshire
-
Lebanon、New Hampshire、アメリカ、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Camden、New Jersey、アメリカ、08103
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
-
East Orange、New Jersey、アメリカ、07018-1095
- Veterans Affairs Medical Center - East Orange
-
Marlton、New Jersey、アメリカ、08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
-
New Brunswick、New Jersey、アメリカ、08903
- Saint Peter's University Hospital
-
Toms River、New Jersey、アメリカ、08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
-
Voorhees、New Jersey、アメリカ、08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
-
-
New York
-
Brooklyn、New York、アメリカ、11201
- Long Island College Hospital
-
Buffalo、New York、アメリカ、14263-0001
- Roswell Park Cancer Institute
-
New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
-
Syracuse、New York、アメリカ、13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Asheville、North Carolina、アメリカ、28801
- Mission Hospitals - Memorial Campus
-
Charlotte、North Carolina、アメリカ、28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Goldsboro、North Carolina、アメリカ、27534
- Wayne Memorial Hospital, Incorporated
-
Greenville、North Carolina、アメリカ、27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
-
Statesville、North Carolina、アメリカ、28677
- Iredell Memorial Hospital
-
Winston-Salem、North Carolina、アメリカ、27103
- Forsyth Regional Cancer Center at Forsyth Medical Center
-
-
Ohio
-
Akron、Ohio、アメリカ、44307
- McDowell Cancer Center at Akron General Medical Center
-
Akron、Ohio、アメリカ、44309-2090
- Akron City Hospital
-
Cincinnati、Ohio、アメリカ、45267
- Charles M. Barrett Cancer Center at University Hospital
-
Columbus、Ohio、アメリカ、43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
-
Mayfield Heights、Ohio、アメリカ、44124
- Hillcrest Cancer Center at Hillcrest Hospital
-
-
Oregon
-
Portland、Oregon、アメリカ、97239-3098
- Oregon Health & Science University Cancer Institute
-
-
Pennsylvania
-
Abington、Pennsylvania、アメリカ、19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
-
Bryn Mawr、Pennsylvania、アメリカ、19010
- Bryn Mawr Hospital
-
East Stroudsburg、Pennsylvania、アメリカ、18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
-
Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Paoli、Pennsylvania、アメリカ、19301-1792
- Cancer Center of Paoli Memorial Hospital
-
Philadelphia、Pennsylvania、アメリカ、19111-2497
- Fox Chase Cancer Center - Philadelphia
-
Philadelphia、Pennsylvania、アメリカ、19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
-
Pittsburgh、Pennsylvania、アメリカ、15219
- Mercy Cancer Institute at Mercy Hospital
-
Reading、Pennsylvania、アメリカ、19612-6052
- Reading Hospital and Medical Center
-
Sayre、Pennsylvania、アメリカ、18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
-
State College、Pennsylvania、アメリカ、16803
- Mount Nittany Medical Center
-
Wynnewood、Pennsylvania、アメリカ、19096
- CCOP - MainLine Health
-
Wynnewood、Pennsylvania、アメリカ、19096
- Lankenau Cancer Center at Lankenau Hospital
-
York、Pennsylvania、アメリカ、17405
- York Cancer Center at Apple Hill Medical Center
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、29425
- Hollings Cancer Center at Medical University of South Carolina
-
Greenville、South Carolina、アメリカ、29615
- CCOP - Greenville
-
Greenville、South Carolina、アメリカ、29601
- Bon Secours St. Francis Health System
-
Spartanburg、South Carolina、アメリカ、29303
- CCOP - Upstate Carolina
-
Spartanburg、South Carolina、アメリカ、29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City、South Dakota、アメリカ、57701
- Rapid City Regional Hospital
-
-
Tennessee
-
Kingsport、Tennessee、アメリカ、37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
-
Knoxville、Tennessee、アメリカ、37916
- Thompson Cancer Survival Center
-
-
Texas
-
Houston、Texas、アメリカ、77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
Temple、Texas、アメリカ、76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Murray、Utah、アメリカ、84107
- Cottonwood Hospital Medical Center
-
Ogden、Utah、アメリカ、84403
- McKay-Dee Hospital Center
-
Provo、Utah、アメリカ、84604
- Utah Valley Regional Medical Center - Provo
-
Saint George、Utah、アメリカ、84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City、Utah、アメリカ、84106
- Utah Cancer Specialists at UCS Cancer Center
-
Salt Lake City、Utah、アメリカ、84143
- Latter Day Saints Hospital
-
-
Virginia
-
Danville、Virginia、アメリカ、24541
- Danville Regional Medical Center
-
Richmond、Virginia、アメリカ、23249
- Veterans Affairs Medical Center - Richmond
-
Richmond、Virginia、アメリカ、23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
Washington
-
Bellingham、Washington、アメリカ、98225
- St. Joseph Cancer Center
-
Seattle、Washington、アメリカ、98101
- CCOP - Virginia Mason Research Center
-
Seattle、Washington、アメリカ、98195-6043
- University Cancer Center at University of Washington Medical Center
-
-
West Virginia
-
Wheeling、West Virginia、アメリカ、26003
- Schiffler Cancer Center at Wheeling Hospital
-
-
Wisconsin
-
Green Bay、Wisconsin、アメリカ、54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay、Wisconsin、アメリカ、54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay、Wisconsin、アメリカ、54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay、Wisconsin、アメリカ、54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
La Crosse、Wisconsin、アメリカ、54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison、Wisconsin、アメリカ、53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Marinette、Wisconsin、アメリカ、54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin Cancer Center
-
Racine、Wisconsin、アメリカ、53405
- All Saints Cancer Center at All Saints Healthcare
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck meeting the following criteria:
- Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses)
Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors:
- Histologic extracapsular nodal extension
- Histologic involvement of ≥ 2 regional lymph nodes
- Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual.
- Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible provided extracapsular nodal extension or involvement of ≥ 2 regional lymph nodes is histologically confirmed
- American Joint Committee on Cancer (AJCC) pathological stage III or IV
- No evidence of distant metastases
- No synchronous or concurrent head and neck primary tumors
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 8.0 g/dL
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters:
- Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN
Renal
- Creatinine ≤ 1.5 mg/dL
Cardiovascular
- No unstable angina
- No uncontrolled hypertension
- No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)
- No uncontrolled arrhythmia
- No congestive heart failure
- No more than 2 heart-related hospitalizations within the past year
- No other active cardiac disease
Pulmonary
- No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year
Neurologic
- No pre-existing peripheral neuropathy ≥ grade 2
- No uncontrolled seizure disorder
- No active neurological disease
Other
- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anti-epidermal growth factor receptor antibody therapy
Chemotherapy
- More than 3 years since prior cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior head and neck radiotherapy
Surgery
- See Disease Characteristics
Other
- No prior tyrosine kinase inhibitor therapy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：RT + cisplatin + cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
|
400 mg/m^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m^2 intravenously over 60 minutes in weeks 2 through 7.
30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.
60 Gy (2 Gy once a day, 5 times a week)
|
|
実験的：RT + docetaxel + cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
|
400 mg/m^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m^2 intravenously over 60 minutes in weeks 2 through 7.
60 Gy (2 Gy once a day, 5 times a week)
15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease-free Survival
時間枠：From randomization to 2 years
|
Two-year rates are shown (Kaplan-Meier estimates).
Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored).
Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible.
A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.
|
From randomization to 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival
時間枠：From randomization to 2 years
|
Two-year rates are shown (Kaplan-Meier estimates).
Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).
|
From randomization to 2 years
|
|
Treatment Tolerance
時間枠：From start of treatment to end of treatment (protocol treatment lasts seven weeks).
|
Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription.
The percentage of patients determined to be tolerant of treatment are shown.
|
From start of treatment to end of treatment (protocol treatment lasts seven weeks).
|
|
Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)
時間枠：From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.
|
Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity).
The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%.
The unacceptable rate was >30%.
[RTOG = Radiation Therapy Oncology Group]
|
From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.
|
|
Frequency of Other Acute and Late Toxicity
時間枠：From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.
|
Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.
|
From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.
|
|
Local-regional Control
時間枠：From randomization to 2 years
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Two-year rate is shown (cumulative incidence estimate).
Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).
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From randomization to 2 years
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Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival
時間枠：From randomization to two years
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From randomization to two years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Paul M. Harari, MD、University of Wisconsin, Madison
- スタディチェア：Jeffrey N. Myers, MD, PhD, FACS、M.D. Anderson Cancer Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Harari PM, Harris J, Kies MS, et al.: Phase II randomized trial of surgery followed by chemoradiation plus cetuximab for high-risk squamous cell carcinoma of the head and neck (RTOG 0234). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-22, S13, 2007.
- Harari PM, Harris J, Kies MS, Myers JN, Jordan RC, Gillison ML, Foote RL, Machtay M, Rotman M, Khuntia D, Straube W, Zhang Q, Ang K. Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234. J Clin Oncol. 2014 Aug 10;32(23):2486-95. doi: 10.1200/JCO.2013.53.9163. Epub 2014 Jul 7.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2004年4月1日
一次修了 (実際)
2009年3月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2004年6月10日
QC基準を満たした最初の提出物
2004年6月10日
最初の投稿 (見積もり)
2004年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月12日
QC基準を満たした最後の更新が送信されました
2018年11月15日
最終確認日
2016年12月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- RTOG-0234
- CDR0000360850
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。