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OpenTrials
Completed

NCT Number: NCT00002951

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorouracil

Drug

Hydroxyurea

Drug

Surgical Procedure

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Locoregional control rate

    Time frame: 8 years

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
2004
Study completion
2006
First posted
Jan 27, 2003
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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