Clinical trial NCT00004234: Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Oral Complications
Keywords: 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
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Centre for the Southern Interior
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Valley Centre at Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: St. Johns
country: Canada
facility: Newfoundland Cancer Treatment and Research Foundation
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Margaret and Charles Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Fleurimont
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: McGill Cancer Centre
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Georg A. Bjarnason, MD, FRCPC
role: STUDY_CHAIR
References:
citation: Bjarnason GA, Mackenzie RG, Nabid A, Hodson ID, El-Sayed S, Grimard L, Brundage M, Wright J, Hay J, Ganguly P, Leong C, Wilson J, Jordan RC, Walker M, Tu D, Parulekar W; National Cancer Institute of Canada Clinical Trials Group (HN3). 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. 2009 Jan 1;73(1):166-72. doi: 10.1016/j.ijrobp.2008.07.009. Epub 2008 Sep 19.
citation: 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 .