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

Head and Neck Cancer Clinical Trial

Official title:

Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002951
• Other study ID #: 8176
• Secondary ID: UCCRC-8176NU-V96
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 4, 2013
• Start date: June 1996
• Est. completion date: July 2006

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2006
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• fluorouracil

• hydroxyurea

Procedure:
• surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	CCOP - Evanston	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional control rate		8 years	No