NCT00005088

Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer

A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 0 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in treating patients who have advanced head and neck cancer.

Detailed description

OBJECTIVES: I. Determine the rate of local regional recurrence at one year in patients with advanced head and neck cancer treated with boost radiotherapy and cisplatin. II. Determine the feasibility of treatment delivery, patient tolerance, and acute and late toxicities in these patients on this regimen. III. Determine the overall survival, disease free survival, and distant relapse rates of these patients on this regimen. OUTLINE: Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days for 6 weeks, and cisplatin IV over 1-2 hours on days 1 and 22. Patients may undergo salvage surgery if biopsy proven cancer remains more than 3 months after treatment. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually until death. PROJECTED ACCRUAL: A total of 50-56 patients will be accrued for this study within 7 months.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
RADIATION	radiation therapy

Timeline

• Start date: 2000-04-01
• Primary completion: 2002-01-01
• First posted: 2004-05-26
• Last updated: 2020-10-22

Locations

258 sites across 2 countries: United States, Canada