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
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|ClinicalTrials.gov Identifier: NCT00081029|
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 8, 2004
Last Update Posted : March 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Radiation Toxicity Xerostomia||Procedure: management of therapy complications Radiation: radiation therapy||Phase 3|
- 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.
- 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 at baseline, at 2 weeks, and then at 3, 6, 12, 18, and 24 months after the completion of radiotherapy.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Official Title:||A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer|
|Study Start Date :||January 2004|
|Estimated Primary Completion Date :||January 2013|
- Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081029
|Cambridge, England, United Kingdom, CB2 2QQ|
|Princess Royal Hospital at Hull and East Yorkshire NHS Trust|
|Hull, England, United Kingdom, HU8 9HE|
|Ipswich, England, United Kingdom, IP4 5PD|
|Barts and the London School of Medicine|
|London, England, United Kingdom, EC1M 6BQ|
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|University College Hospital - London|
|London, England, United Kingdom, WC1E 6AU|
|Manchester, England, United Kingdom, M20 4BX|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|University Hospital of North Staffordshire|
|Stoke-On-Trent, England, United Kingdom, ST4 7LN|
|Study Chair:||Chris Nutting||Royal Marsden NHS Foundation Trust|