Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer - Full Text View

Purpose

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


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Hydroxyurea

Genetic and Rare Diseases Information Center resources: Oral Cancer Nasopharyngeal Carcinoma Esophageal Cancer Lip and Oral Cavity Cancer Laryngeal Cancer Hypopharyngeal Cancer

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Locoregional control rate [ Time Frame: 8 years ] [ Designated as safety issue: No ]


Enrollment:	53
Study Start Date:	June 1996
Study Completion Date:	July 2006
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

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.


Responsible Party:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00002951 History of Changes
Other Study ID Numbers:	8176 UCCRC-8176 NU-V96N1 NCI-G97-1159
Study First Received:	November 1, 1999
Last Updated:	September 4, 2013
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 30, 2016