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

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ClinicalTrials.gov Identifier: NCT00002951
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 5, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Esophageal Cancer Head and Neck Cancer Drug: fluorouracil Drug: hydroxyurea Procedure: surgical procedure Radiation: radiation therapy Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck
Study Start Date : June 1996
Actual Primary Completion Date : June 2004
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A (Hyper-FHX)
Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
 Drug: fluorouracil Drug: hydroxyurea Procedure: surgical procedure Radiation: radiation therapy


Outcome Measures
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Primary Outcome Measures :
  1. Locoregional control rate [ Time Frame: 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002951


Locations
United States, Illinois
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
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
CCOP - Evanston
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Investigators
Study Chair: Everett E. Vokes, MD University of Chicago
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00002951     History of Changes
Other Study ID Numbers: 8176
UCCRC-8176
NU-V96N1
NCI-G97-1159
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Esophageal Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorouracil
Hydroxyurea
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors