Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081029
Status:
UNKNOWN
Last Update Posted:
2011-03-23
First Post:
2004-04-07
Brief Title:
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
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
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 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
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 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ICR-PARSPORT | None | None | None |
| EU-20304 | None | None | None |
| ISRCTN48243537 | None | None | None |
| MREC-03679 | None | None | None |