Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095927
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2004-11-09
Brief Title:
Randomized Amifostine For SCCHN
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Randomized Study of Concomitant Chemoradiation Using Weekly CarboplatinumPaclitaxel With Arm A or Without Arm B Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
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:
This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head andor neck area
Detailed Description:
Amifostine is a drug that is used to treat moderate to severe xerostomia dry mouth for those who receive radiation therapy for head and neck cancer It was approved by the FDA for use intravenously This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously by injection Amifostine has been seen to be effective when used to combat the effects of dry mouth but also has some side effects which are listed later in this consent form
The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel Taxo 1 This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation
The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel Taxo 1 This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA006516 | NIH | None | httpsreporternihgovquickSearchP30CA006516 |