Clinical trial NCT00057785
Conditions: Head and Neck Cancer Oral Complications of Radiation Therapy Radiation Toxicity
Keywords: oral complications of radiation therapy radiation toxicity stage I squamous cell carcinoma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx
Sponsor: Radiation Therapy Oncology Group
Start date: 2003-02-01; Completion date: 2016-12-01
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Interventions: intervention 1: cisplatin intervention 2: fluorouracil intervention 3: Intensity modulated radiation therapy
Intervention descriptions: intervention 1: 100 mg/m\^2 intravenously on days 1, 22, and 43 and 80 mg/m\^2 intravenously on days 71, 99, and 127 intervention 2: 1000 mg/m\^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130 intervention 3: 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.

Protocol documents: