NCT00006360

Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.

Detailed description

OBJECTIVES: * Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy. * Determine the nature and prevalence of acute and late side effects of this treatment in these patients. * Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment. OUTLINE: This is a multicenter study. Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.

Conditions

• Head and Neck Cancer
• Radiation Toxicity

Interventions

Type	Name	Description
DRUG	radioprotection
RADIATION	radiation therapy

Timeline

• Start date: 2001-02-01
• Primary completion: 2005-11-01
• Completion: 2016-12-01
• First posted: 2003-01-27
• Last updated: 2020-10-22

Locations

18 sites across 2 countries: United States, Canada