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

NCT ID: NCT00002951

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-06-30
• Study Completion Date: 2006-07-31

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.

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.

Conditions

Esophageal Cancer; Head and Neck Cancer

Keywords

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

fluorouracil

Intervention Type: DRUG

hydroxyurea

Intervention Type: DRUG

surgical procedure

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Interventions

fluorouracil

Intervention Type: DRUG

hydroxyurea

Intervention Type: DRUG

surgical procedure

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Everett E. Vokes, MD

Role: STUDY_CHAIR

University of Chicago

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

CCOP - Evanston

Evanston, Illinois, United States

Countries

United States

References

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. doi: 10.1200/JCO.2006.05.8529.

Reference Type: RESULT

PMID: 16849759 (View on PubMed)

Other Identifiers

UCCRC-8176

Identifier Type: -

Identifier Source: secondary_id

NU-V96N1

Identifier Type: -

Identifier Source: secondary_id

NCI-G97-1159

Identifier Type: -

Identifier Source: secondary_id

8176

Identifier Type: -

Identifier Source: org_study_id