Spots Global Cancer Trial Database for Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx

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Trial Identification

Brief Title: Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx

Official Title: A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck

Study ID: NCT00004234

Conditions

Head and Neck Cancer

Oral Complications

Interventions

management of therapy complications

radiation therapy

Study Description

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy at different times of the day may affect the chance of developing side effects such as mucositis. PURPOSE: Randomized phase III trial to compare the incidence of mucositis in patients who have cancer of the mouth, pharynx, or larynx, who are receiving radiation therapy in either the morning or afternoon.

Detailed Description: OBJECTIVES: * Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in the late afternoon in patients with squamous cell carcinoma of the oral cavity, pharynx (oro/hypo/naso), or larynx who will receive radiation treatment to a significant part of the oral and/or oropharyngeal mucosa. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, intended smoking behavior during therapy (smoking vs nonsmoking), and planned total radiotherapy dose. Patients are randomized to receive radiotherapy once daily, 5 days a week, at one of two of the following times of the day: * Arm I: Patients receive radiotherapy between 8 and 10 AM (local time). * Arm II: Patients receive radiotherapy between 4 and 6 PM (local time). Treatment continues for 5-8 weeks, depending on planned total radiotherapy dose, in the absence of unacceptable toxicity or disease progression. Toxicity is assessed at baseline, at the first fraction of radiotherapy, weekly during treatment, weekly until mucositis has peaked and is improving, and then every 2 weeks until mucositis has improved to less than grade 2. Quality of life is assessed at baseline, weekly during treatment and until toxicity has peaked and is improving, every 2 weeks until toxicity is less than grade 2 mucositis, and then at each follow-up visit until week 24. Patients are followed at weeks 2-3, 6-8, 12, and 24 and then annually for 3 years. PROJECTED ACCRUAL: A total of 216 patients (108 per treatment arm) will be accrued for this study.