Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

NCIC-Clinical Trials Group

Georg A. Bjarnason

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004234
Information obtained from ClinicalTrials.gov on December 14, 2011

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