Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003580
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
Sponsor:
University of Tennessee
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study - Efficacy of Amifostine in Alleviating Toxicity Associated With Targeted Supradose Cisplatin and Concomitant Radiation Therapy RADPLAT in Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2006-05
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy
PURPOSE Phase II trial to study the effectiveness of amifostine in treating side effects of treatment in patients receiving radiation therapy and cisplatin for advanced head and neck cancer
PURPOSE Phase II trial to study the effectiveness of amifostine in treating side effects of treatment in patients receiving radiation therapy and cisplatin for advanced head and neck cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of amifostine in alleviating treatment related mucositis associated with targeted supradose cisplatin and concurrent radiotherapy RADPLAT protocol in patients with stage III or IV squamous cell carcinoma of the head and neck II Determine the efficacy of amifostine in alleviating other treatment related morbidities associated with this protocol in these patients
OUTLINE This is an open label multicenter study of amifostine Patients receive external beam radiotherapy 5 days a week for approximately 65-75 weeks Concurrent with radiotherapy patients receive amifostine IV over 10 minutes 30 minutes prior to cisplatin then cisplatin intra-arterially over 3-5 minutes Chemotherapy and amifostine course is repeated every week for 4 weeks Patients are followed at 1 month
PROJECTED ACCRUAL Approximately 30 patients will be accrued into this study over 12-18 months
OUTLINE This is an open label multicenter study of amifostine Patients receive external beam radiotherapy 5 days a week for approximately 65-75 weeks Concurrent with radiotherapy patients receive amifostine IV over 10 minutes 30 minutes prior to cisplatin then cisplatin intra-arterially over 3-5 minutes Chemotherapy and amifostine course is repeated every week for 4 weeks Patients are followed at 1 month
PROJECTED ACCRUAL Approximately 30 patients will be accrued into this study over 12-18 months
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 |
|---|---|---|---|
| CDR0000066647 | REGISTRY | None | None |
| ALZA-98-066-ii | None | None | None |
| NCI-V98-1472 | Registry Identifier | PDQ Physician Data Query | None |