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S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

2011年7月21日更新者：Southwest Oncology Group

Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer

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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.

研究概览

地位

完全的

条件

头颈癌

干预/治疗

详细说明

OBJECTIVES:

Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated fractionation/concomitant boost radiotherapy and cisplatin.
Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy.
Determine the overall complete response rate (confirmed and unconfirmed) in patients treated with this regimen.
Determine the toxic effects of this regimen in these patients.

OUTLINE:

Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity.
Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course of induction chemotherapy, patients receive accelerated fractionation radiotherapy once daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5 days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

研究类型

介入性

阶段

阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Ontario
  - Toronto、Ontario、加拿大、M5G 1X8
    - Hospital for Sick Children
美国
- Alabama
  - Birmingham、Alabama、美国、35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile、Alabama、美国、36607
    - MBCCOP - Gulf Coast
- Arizona
  - Phoenix、Arizona、美国、85006-2726
    - CCOP - Western Regional, Arizona
  - Phoenix、Arizona、美国、85012
    - Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
  - Tucson、Arizona、美国、85723
    - Veterans Affairs Medical Center - Tucson
  - Tucson、Arizona、美国、85724
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock、Arkansas、美国、72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  - Little Rock、Arkansas、美国、72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Duarte、California、美国、91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fresno、California、美国、93720
    - California Cancer Center
  - Los Angeles、California、美国、90033
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez、California、美国、94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland、California、美国、94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange、California、美国、92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  - Sacramento、California、美国、95817
    - University of California Davis Cancer Center
  - Santa Rosa、California、美国、95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base、California、美国、94535
    - David Grant Medical Center
- Colorado
  - Aurora、Colorado、美国、80010
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
  - Denver、Colorado、美国、80220
    - Veterans Affairs Medical Center - Denver
- District of Columbia
  - Washington、District of Columbia、美国、20060
    - MBCCOP - Howard University Cancer Center
- Florida
  - Tampa、Florida、美国、33612
    - Veterans Affairs Medical Center - Tampa (Haley)
- Georgia
  - Atlanta、Georgia、美国、30342-1701
    - CCOP - Atlanta Regional
- Hawaii
  - Honolulu、Hawaii、美国、96813
    - MBCCOP - Hawaii
- Illinois
  - Chicago、Illinois、美国、60612
    - Veterans Affairs Medical Center - Chicago (Westside Hospital)
  - Chicago、Illinois、美国、60612
    - MBCCOP - University of Illinois at Chicago
  - Decatur、Illinois、美国、62526
    - CCOP - Central Illinois
  - Hines、Illinois、美国、60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood、Illinois、美国、60153-5500
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Kansas
  - Kansas City、Kansas、美国、66160-7353
    - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  - Wichita、Kansas、美国、67214-3882
    - CCOP - Wichita
  - Wichita、Kansas、美国、67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington、Kentucky、美国、40502-2236
    - Veterans Affairs Medical Center - Lexington
  - Lexington、Kentucky、美国、40536-0084
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
- Louisiana
  - New Orleans、Louisiana、美国、70112
    - Veterans Affairs Medical Center - New Orleans
  - New Orleans、Louisiana、美国、70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans、Louisiana、美国、70112
    - Tulane Cancer Center at Tulane University Hospital and Clinic
  - Shreveport、Louisiana、美国、71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport、Louisiana、美国、71101-4295
    - Veterans Affairs Medical Center - Shreveport
- Massachusetts
  - Boston、Massachusetts、美国、02118
    - Cancer Research Center at Boston Medical Center
- Michigan
  - Ann Arbor、Michigan、美国、48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor、Michigan、美国、48106
    - CCOP - Michigan Cancer Research Consortium
  - Ann Arbor、Michigan、美国、48109-0912
    - University of Michigan Comprehensive Cancer Center
  - Detroit、Michigan、美国、48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Detroit、Michigan、美国、48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Detroit、Michigan、美国、48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Grand Rapids、Michigan、美国、49503
    - CCOP - Grand Rapids
  - Royal Oak、Michigan、美国、48073-6769
    - CCOP - Beaumont
  - Southfield、Michigan、美国、48075
    - Providence Cancer Institute at Providence Hospital
- Mississippi
  - Jackson、Mississippi、美国、39216-4505
    - University of Mississippi Medical Center
  - Jackson、Mississippi、美国、39216
    - Veterans Affairs Medical Center - Jackson
- Missouri
  - Kansas City、Missouri、美国、64131
    - CCOP - Kansas City
  - Saint Louis、Missouri、美国、63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis、Missouri、美国、63110
    - St. Louis University Hospital Cancer Center
  - Springfield、Missouri、美国、65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings、Montana、美国、59101
    - CCOP - Montana Cancer Consortium
- New Jersey
  - East Orange、New Jersey、美国、07018-1095
    - Veterans Affairs Medical Center - East Orange
- New Mexico
  - Albuquerque、New Mexico、美国、87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque、New Mexico、美国、87131
    - MBCCOP - University of New Mexico HSC
- New York
  - New York、New York、美国、10016
    - NYU School of Medicine's Kaplan Comprehensive Cancer Center
  - New York、New York、美国、10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Rochester、New York、美国、14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
- North Carolina
  - Salisbury、North Carolina、美国、28144
    - Veterans Affairs Medical Center - Salisbury
  - Winston-Salem、North Carolina、美国、27104-4241
    - CCOP - Southeast Cancer Control Consortium
- Ohio
  - Cincinnati、Ohio、美国、45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cincinnati、Ohio、美国、45267-0501
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland、Ohio、美国、44195-9001
    - Cleveland Clinic Taussig Cancer Center
  - Columbus、Ohio、美国、43206
    - CCOP - Columbus
  - Dayton、Ohio、美国、45429
    - CCOP - Dayton
  - Dayton、Ohio、美国、45428-1002
    - Veterans Affairs Medical Center - Dayton
- Oregon
  - Portland、Oregon、美国、97207
    - Veterans Affairs Medical Center - Portland
  - Portland、Oregon、美国、97225
    - CCOP - Columbia River Oncology Program
  - Portland、Oregon、美国、97201-3098
    - Cancer Institute at Oregon Health and Science University
- South Carolina
  - Charleston、South Carolina、美国、29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Charleston、South Carolina、美国、29401-5799
    - Veterans Affairs Medical Center - Charleston
  - Greenville、South Carolina、美国、29615
    - CCOP - Greenville
  - Spartanburg、South Carolina、美国、29303
    - CCOP - Upstate Carolina
- Tennessee
  - Memphis、Tennessee、美国、38104
    - University of Tennessee Cancer Institute
- Texas
  - Amarillo、Texas、美国、79106
    - Harrington Cancer Center
  - Amarillo、Texas、美国、79106
    - Veterans Affairs Medical Center - Amarillo
  - Fort Sam Houston、Texas、美国、78234-6200
    - Brooke Army Medical Center
  - Galveston、Texas、美国、77555-0565
    - University of Texas Medical Branch
  - Houston、Texas、美国、77030
    - Veterans Affairs Medical Center - Houston
  - Houston、Texas、美国、77030-4095
    - University of Texas - MD Anderson Cancer Center
  - San Antonio、Texas、美国、78229-3900
    - University of Texas Health Science Center at San Antonio
  - San Antonio、Texas、美国、78229
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - Temple、Texas、美国、76504
    - Veterans Affairs Medical Center - Temple
  - Temple、Texas、美国、76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City、Utah、美国、84148
    - Veterans Affairs Medical Center - Salt Lake City
  - Salt Lake City、Utah、美国、84112-5550
    - Huntsman Cancer Institute
- Washington
  - Seattle、Washington、美国、98101
    - CCOP - Virginia Mason Research Center
  - Seattle、Washington、美国、98108
    - Veterans Affairs Medical Center - Seattle
  - Seattle、Washington、美国、98109
    - Puget Sound Oncology Consortium
  - Tacoma、Washington、美国、98431-5000
    - Madigan Army Medical Center
  - Tacoma、Washington、美国、98405-0986
    - CCOP - Northwest

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the head and neck (excluding lip, nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate of the primary lesion or neck mass
- Stage III or IV disease
No evidence of distant metastases
- Negative chest x-ray
Primary site in the head and neck region must be identified
- No unknown primary site
Considered to be appropriate for definitive radiotherapy with curative intent

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Granulocyte count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic

Bilirubin no greater than upper limit of normal (ULN)
Alkaline phosphatase less than 2 times ULN
ALT or AST less than 1.5 times ULN

Renal

Creatinine less than 1.5 mg/dL

Cardiovascular

No myocardial infarction within the past 3 months
No unstable or uncontrolled angina

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
No evidence of pre-existing peripheral neuropathy
No active systemic infection
No history of hypersensitivity reaction to products containing polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
No prior radiotherapy

Surgery

No prior surgery for head or neck cancer

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Southwest Oncology Group

合作者

National Cancer Institute (NCI)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Adelstein DJ, Moon J, Hanna E, Giri PG, Mills GM, Wolf GT, Urba SG. Docetaxel, cisplatin, and fluorouracil induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced squamous cell head and neck cancer: A Southwest Oncology Group phase II trial (S0216). Head Neck. 2010 Feb;32(2):221-8. doi: 10.1002/hed.21179.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年4月1日

初级完成 (实际的)

2007年11月1日

研究注册日期

首次提交

2003年2月5日

首先提交符合 QC 标准的

2003年2月5日

首次发布 (估计)

2003年2月6日

研究记录更新

最后更新发布 (估计)

2011年7月25日

上次提交的符合 QC 标准的更新

2011年7月21日

最后验证

2011年7月1日

多西紫杉醇的临床试验

Yonsei University

未知

多西紫杉醇和 S1 (DS) 与 S1 和顺铂 (SP) 在根治性切除的 IIIB/IV 期胃癌中的对比

胃腺癌

大韩民国