Head and Neck Cancer Clinical Trial
Official title:
Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell 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 more than one chemotherapy drug with radiation therapy may kill more tumor
cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation
therapy in treating patients with stage III or stage IV head and neck cancer.
OBJECTIVES:
- Determine the overall survival of patients with stage III or IV squamous cell head and
neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated
fractionation/concomitant boost radiotherapy and cisplatin.
- Determine the unconfirmed complete response rate in these patients after treatment with
induction chemotherapy.
- Determine the overall complete response rate (confirmed and unconfirmed) in patients
treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE:
- Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over
30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats
every 21 days for 2 courses in the absence of unacceptable toxicity.
- Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course
of induction chemotherapy, patients receive accelerated fractionation radiotherapy once
daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5
days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent
cisplatin IV over 30-60 minutes on days 1 and 22.
Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months
for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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