Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00004234
First received: January 28, 2000
Last updated: November 11, 2013
Last verified: March 2010

January 28, 2000
November 11, 2013
August 1999
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004234 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Supportive Care
  • Head and Neck Cancer
  • Oral Complications
  • Procedure: management of therapy complications
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2009
Not Provided

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00004234
HN3, CAN-NCIC-HN3, CDR0000067478
Not Provided
NCIC Clinical Trials Group
NCIC Clinical Trials Group
Not Provided
Study Chair: Georg A. Bjarnason, MD, FRCPC Edmond Odette Cancer Centre at Sunnybrook
NCIC Clinical Trials Group
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP