Head and Neck Cancer Clinical Trial
Official title:
Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may
kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use
different ways to stop tumor cells from dividing so they stop growing or die. Combining
high-dose radiation with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy
with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage
IV nasopharyngeal cancer.
OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting
toxicity.
Phase I
- Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks
beginning on day 1.
- Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5
and 22-26.
- Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy,
patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30
minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the
absence of disease progression or unacceptable toxicity.
In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to
phase II.
Phase II
- Patients are treated as in phase I. Patients are followed every 3 months for 1 year,
every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
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