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


Phase 2
N/A
N/A
Not Enrolling
Both
Esophageal Cancer, Head and Neck Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Locoregional control rate

Outcome Time Frame:

8 years

Safety Issue:

No

Principal Investigator

Everett E. Vokes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

8176

NCT ID:

NCT00002951

Start Date:

June 1996

Completion Date:

July 2006

Related Keywords:

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - EvanstonEvanston, Illinois  60201
Louis A. Weiss Memorial HospitalChicago, Illinois  60640