NCT00006051

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

Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 70 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 plus radiation therapy in treating patients who have head and neck cancer.

Detailed description

OBJECTIVES: I. Determine the toxicity of fluorouracil and cisplatin with concurrent radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high risk of recurrence following curative resection. II. Determine the efficacy of this regimen in these patients. III. Determine the survival of these patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive fluorouracil IV continuously on days 1-5 and 43-47 and cisplatin IV over 1 hour on days 2, 23, and 44. Concurrent radiotherapy is administered 5 days a week for 6.5 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 44-68 patients will be accrued for this study within 18 months.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	fluorouracil
RADIATION	radiation therapy

Timeline

• Start date: 1999-02-01
• Primary completion: 2002-08-01
• Completion: 2005-09-01
• First posted: 2004-03-25
• Last updated: 2021-02-21

Locations

6 sites across 1 country: France