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

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00004234

Collaborator

(none)

Locations

114.3

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Oral Complications	Procedure: management of therapy complications Radiation: radiation therapy	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

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

Actual Study Start Date :

Aug 2, 1999

Actual Primary Completion Date :

Mar 11, 2005

Actual Study Completion Date :

Feb 10, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
2	Fraser Valley Centre at Surrey Memorial Hospital	Surrey	British Columbia	Canada	V3V 1Z2
3	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
4	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
5	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
6	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
7	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
8	Ottawa Regional Cancer Centre	Ottawa	Ontario	Canada	K1H 1C4
9	Regional Cancer Care at Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario	Canada	P7B 6V4
10	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
11	CHUS-Hopital Fleurimont	Fleurimont	Quebec	Canada	J1H 5N4
12	McGill Cancer Centre	Montreal	Quebec	Canada	H2W 1S6
13	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec	Canada	G1R 2J6
14	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4