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Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002951
  Purpose

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 radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.


Condition Intervention Phase
Esophageal Cancer
Head and Neck Cancer
Drug: fluorouracil
Drug: hydroxyurea
Procedure: radiation therapy
Procedure: surgical procedure
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Head and Neck Cancer   

ChemIDplus related topics:   Hydroxyurea    Fluorouracil    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck

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

Estimated Enrollment:   40
Study Start Date:   June 1996

Detailed Description:

OBJECTIVES:

  • Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus.
  • Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters.
  • Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring.

OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.

The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.

The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of carcinoma
  • Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus
  • No N2 or N3
  • Measurable disease is not required

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-3

Life expectancy:

  • Anticipated survival is 3-4 years (median)

Hematopoietic:

  • WBC count at least 3.5/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • Not specified

Pulmonary:

  • Not specified

Other:

  • No infection or severe medical illness
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • No prior surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002951

Locations
United States, Illinois
CCOP - Evanston    
      Evanston, Illinois, United States, 60201
Louis A. Weiss Memorial Hospital    
      Chicago, Illinois, United States, 60640
Robert H. Lurie Comprehensive Cancer Center, Northwestern University    
      Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637-1470

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Everett E. Vokes, MD     University of Chicago    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000065421, UCCRC-8176, NU-V96N1, NCI-G97-1159
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002951
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II esophageal cancer  
stage III esophageal cancer  
stage II nasopharyngeal cancer  
stage III nasopharyngeal cancer  
stage II lip and oral cavity cancer  
stage III lip and oral cavity cancer  
stage II hypopharyngeal cancer  
stage III hypopharyngeal cancer
stage II laryngeal cancer
stage III laryngeal cancer
stage II paranasal sinus and nasal cavity cancer
stage III paranasal sinus and nasal cavity cancer
stage II oropharyngeal cancer
stage III oropharyngeal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Hydroxyurea
Gastrointestinal Diseases
Esophageal Neoplasms
Salicylsalicylic acid
Sodium Salicylate
Laryngeal Neoplasms
Lip and oral cavity cancer
Digestive System Diseases
Nasopharyngeal carcinoma
Fluorouracil
Head and Neck Neoplasms
Oral cancer
Gastrointestinal Neoplasms
Laryngeal carcinoma
Hypopharyngeal cancer
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Antisickling Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hematologic Agents
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 27, 2008




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