Clinical Trial: Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths directly to the tumor from many angles. This type of radiation therapy may reduce damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life. It is not yet known whether intensity-modulated radiation therapy is more effective than conventional radiation therapy in preventing xerostomia and improving quality of life in patients who have throat cancer.

PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared to conventional radiation therapy in treating patients with oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused by radiation therapy.


Detailed Summary:

OBJECTIVES:

Primary

  • Compare the proportion of patients with oropharyngeal or hypopharyngeal cancer with xerostomia of ≥ grade 2 at one year after treatment with parotid-sparing intensity-modulated radiotherapy vs conventional radiotherapy.

Secondary

  • Compare the degree of xerostomia by quantitative measurements of stimulated and unstimulated salivary flow in patients treated with these regimens.
  • Compare quality of life in patients treated with these regimens.
  • Compare local and regional tumor control, time to tumor progression, and overall survival of patients treated with these regimens.
  • Compare acute and late side effects of these regimens in these patients.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and site of disease (oropharynx vs hypopharynx). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo parotid-sparing intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks.
  • Arm II: Patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.

Salivary flow measurements are performed at baseline, at week 4 during radiotherapy, and then at 2 weeks and at 3, 6, 12, and 24 months after the completion of radiotherapy.

Quality of life is assessed
Sponsor: Royal Marsden NHS Foundation Trust

Current Primary Outcome: Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year

Original Primary Outcome:

Current Secondary Outcome:

  • Degree of xerostomia by salivary flow at 1 year
  • Xerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year
  • Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year
  • Local and regional tumor control by a quantitative description of sites of relapse at 1 year
  • Time to tumor progression at 1 year
  • Overall survival at 1 year
  • Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year
  • Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: April 7, 2004
Date Started: January 2004
Date Completion:
Last Updated: March 22, 2011
Last Verified: March 2008