Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
- Conditions
- Oral ComplicationsHead and Neck Cancer
- Registration Number
- NCT00004234
- Lead Sponsor
- NCIC Clinical Trials Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
McGill Cancer Centre
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Fraser Valley Centre at Surrey Memorial Hospital
🇨🇦Surrey, British Columbia, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada