NCT00057785

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. 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 specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.

Detailed description

OBJECTIVES: * Determine the transportability of IMRT to a multi-institutional setting. * Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy (IMRT) with or without chemotherapy. * Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens. * Determine the rate of local-regional control, distant metastasis, and disease-free and overall survival of patients treated with these regimens. * Determine the acute and late toxicity of these regimens in these patients. * Determine chemotherapy compliance in patients treated with these regimens. OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over 20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127. Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12 months after IMRT. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40 months.

Conditions

• Head and Neck Cancer
• Oral Complications of Radiation Therapy
• Radiation Toxicity

Interventions

Type	Name	Description
DRUG	cisplatin	100 mg/m\^2 intravenously on days 1, 22, and 43 and 80 mg/m\^2 intravenously on days 71, 99, and 127
DRUG	fluorouracil	1000 mg/m\^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130
RADIATION	Intensity modulated radiation therapy	The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume \[CTV\] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.

Timeline

• Start date: 2003-02-01
• Primary completion: 2007-02-01
• Completion: 2016-12-01
• First posted: 2003-04-09
• Last updated: 2017-02-17
• Results posted: 2014-10-13

Locations

17 sites across 1 country: United States