Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
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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 |
- 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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Illinois | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| 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 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| Study Chair: | Everett E. Vokes, MD | University of Chicago |
More Information
Additional Information:
Publications:
| Responsible Party: | Everett Vokes, Chairman, Department of Medicine, 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: | February 5, 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:
|
Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Fluorouracil Hydroxyurea Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antisickling Agents Hematologic Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013