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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Everett Vokes, University of Chicago
ClinicalTrials.gov Identifier:
NCT00002951
First received: November 1, 1999
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

November 1, 1999
February 5, 2013
June 1996
June 2004   (final data collection date for primary outcome measure)
Locoregional control rate [ Time Frame: 8 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002951 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage 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. 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.

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Head and Neck Cancer
  • Drug: fluorouracil
  • Drug: hydroxyurea
  • Procedure: surgical procedure
  • Radiation: radiation therapy
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)
Interventions:
  • Drug: fluorouracil
  • Drug: hydroxyurea
  • Procedure: surgical procedure
  • Radiation: radiation therapy
Cohen EE, Haraf DJ, List MA, Kocherginsky M, Mittal BB, Rosen F, Brockstein B, Williams R, Witt ME, Stenson KM, Kies MS, Vokes EE. High survival and organ function rates after primary chemoradiotherapy for intermediate-stage squamous cell carcinoma of the head and neck treated in a multicenter phase II trial. J Clin Oncol. 2006 Jul 20;24(21):3438-44.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2006
June 2004   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002951
8176, UCCRC-8176, NU-V96N1, NCI-G97-1159
No
Everett Vokes, University of Chicago
University of Chicago
National Cancer Institute (NCI)
Study Chair: Everett E. Vokes, MD University of Chicago
University of Chicago
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP