![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Royal Marsden - London |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081029 |
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 | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Head and Neck Cancer |
Procedure: management of therapy complications Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer |
Estimated Enrollment: | 84 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed oropharyngeal or hypopharyngeal cancer
Primary tumor requiring radical radiotherapy with parallel opposed lateral fields and bilateral cervical lymph node irradiation
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United Kingdom, England | |
Addenbrooke's Hospital | |
Cambridge, England, United Kingdom, CB2 2QQ | |
Barts and the London School of Medicine | |
London, England, United Kingdom, EC1M 6BQ | |
Cancer Research Centre at Weston Park Hospital | |
Sheffield, England, United Kingdom, S1O 2SJ | |
Christie Hospital | |
Manchester, England, United Kingdom, M20 4BX | |
University Hospital of North Staffordshire | |
Stoke-On-Trent, England, United Kingdom, ST4 7LN | |
Princess Royal Hospital at Hull and East Yorkshire NHS Trust | |
Hull, England, United Kingdom, HU8 9HE | |
Royal Marsden - London | |
London, England, United Kingdom, SW3 6JJ | |
University College Hospital - London | |
London, England, United Kingdom, WC1E 6AU | |
Ipswich Hospital | |
Ipswich, England, United Kingdom, IP4 5PD |
Study Chair: | Chris Nutting | Royal Marsden - London |
Study ID Numbers: | CDR0000358803, ICR-PARSPORT, EU-20304, ISRCTN48243537, MREC-03679 |
Study First Received: | April 7, 2004 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00081029 |
Health Authority: | United States: Federal Government |
xerostomia radiation toxicity stage I squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the hypopharynx |
stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the oropharynx |
Epidermoid carcinoma Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell |
Hypopharyngeal cancer Carcinoma, Squamous Cell Xerostomia Carcinoma |
Neoplasms Neoplasms by Site |