Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
|ClinicalTrials.gov Identifier: NCT00004234|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Oral Complications||Procedure: management of therapy complications Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||August 1999|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||February 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004234
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Fraser Valley Centre at Surrey Memorial Hospital|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Newfoundland and Labrador|
|Newfoundland Cancer Treatment and Research Foundation|
|St. Johns, Newfoundland and Labrador, Canada, A1B 3V6|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 1C4|
|Regional Cancer Care at Thunder Bay Regional Health Sciences Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Toronto Sunnybrook Regional Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Fleurimont, Quebec, Canada, J1H 5N4|
|McGill Cancer Centre|
|Montreal, Quebec, Canada, H2W 1S6|
|Centre Hospitalier Universitaire de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Study Chair:||Georg A. Bjarnason, MD, FRCPC||Toronto Sunnybrook Regional Cancer Centre|