A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
16 Years
N/A
Both
Head and Neck Cancer, Oral Complications
Trial Information
A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity,
pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical
radiotherapy
- TX, T1-4, NX, N0-3, M0
- Directly visible area of mucosa including 2 or more protocol specified
anatomical locations in the radical target volume
- At least 6 cm^2 in area irrespective of shape
- No M1 disease
- Intention to deliver radiotherapy to a radical dose without chemotherapy
- May have had surgical resection of the primary or neck nodes
- Postoperative macroscopic or microscopic residual disease that is eligible for
radical radiotherapy is allowed
- Patients with completely resected disease who are judged to be at high risk of
relapse and who are eligible for radical radiotherapy are allowed
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin ≥ 10 g/dL
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- Must have normal sleeping habits (i.e., normal circadian rhythm)
- Must have had dental assessment and necessary prophylactic dental extractions carried
out
- No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective
tissue disease, rheumatoid arthritis)
- No organic brain syndrome related to chronic alcohol excess or other cause of
sufficient severity that would preclude cooperation with treatment
- No active uncontrolled infection
- No history of psychiatric or neurological disorder that would preclude study
compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 6 months since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to the head and neck region
Surgery:
- See Disease Characteristics
Other:
- No other concurrent oral hygiene regimen other than that described in the protocol
- No concurrent radioprotective drugs or therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Georg A. Bjarnason, MD, FRCPC
Investigator Role:
Study Chair
Investigator Affiliation:
Edmond Odette Cancer Centre at Sunnybrook
Authority:
United States: Federal Government
Study ID:
HN3
NCT ID:
NCT00004234
Start Date:
August 1999
Completion Date:
February 2009
Related Keywords:
- Head and Neck Cancer
- Oral Complications
- oral complications
- stage I squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- 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
- recurrent squamous cell carcinoma of the nasopharynx
- stage I squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- Head and Neck Neoplasms
- Mouth Neoplasms
- Stomatitis
- Mucositis
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