NCT00054054

S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	docetaxel
DRUG	fluorouracil
RADIATION	radiation therapy

Timeline

• Start date: 2003-04-01
• Primary completion: 2007-11-01
• First posted: 2003-02-06
• Last updated: 2011-07-25

Locations

95 sites across 2 countries: United States, Canada