Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Closed	16 and over	Other	CAN-NCIC-HN3 NCT00004234, HN3

Objectives

1. 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.

Entry 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 cm² 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

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

Patient Characteristics:

Age:

• 16 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin ≥ 10 g/dL
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 216 patients (108 per treatment arm) will be accrued for this study.

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.

Bjarnason GA, Mackenzie RG, Nabid A, et al.: Comparison of toxicity associated with early morning versus late afternoon radiotherapy in patients with head-and-neck cancer: a prospective randomized trial of the National Cancer Institute of Canada Clinical Trials Group (HN3). Int J Radiat Oncol Biol Phys 73 (1): 166-72, 2009.[PUBMED Abstract]

Bjarnason GA, MacKenzie R, Hodson I, et al.: A randomized prospective phase-III study comparing the acute oral mucositis of morning vs. afternoon radiotherapy (RT) in patients (pts) with squamous cell carcinoma of the head and neck (SCCHN): NCIC-CTG HN.3. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA5500, 500s, 2005 .

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Georg Bjarnason, MD, FRCPC, Protocol chair		Ph: 416-480-6100 ext. 13982 Email: bjarnason@sri.utoronto.ca

Registry Information
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
Trial Start Date		1999-08-02
Registered in ClinicalTrials.gov		NCT00004234
Date Submitted to PDQ		1999-12-22
Information Last Verified		2006-06-15

Back to Top