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

The University of Chicago

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer; Head and Neck Cancer

Treatments: Procedure: surgical procedure; Radiation: radiation therapy; Drug: hydroxyurea; Drug: fluorouracil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00002951

NCI-G97-1159

NU-V96N1

UCCRC-8176

8176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Arm A (Hyper-FHX)

Experimental group

Description:

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)

Treatment:

Drug: fluorouracil

Procedure: surgical procedure

Drug: hydroxyurea

Radiation: radiation therapy