Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005088
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-04-06
Brief Title:
Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas
Status:
COMPLETED
Status Verified Date:
2013-11
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 Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy and cisplatin in treating patients who have advanced head and neck cancer
PURPOSE Phase II trial to study the effectiveness of radiation therapy and cisplatin in treating patients who have advanced head and neck cancer
Detailed Description:
OBJECTIVES I Determine the rate of local regional recurrence at one year in patients with advanced head and neck cancer treated with boost radiotherapy and cisplatin II Determine the feasibility of treatment delivery patient tolerance and acute and late toxicities in these patients on this regimen III Determine the overall survival disease free survival and distant relapse rates of these patients on this regimen
OUTLINE Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days for 6 weeks and cisplatin IV over 1-2 hours on days 1 and 22 Patients may undergo salvage surgery if biopsy proven cancer remains more than 3 months after treatment Patients are followed every 3 months for 2 years every 6 months for 3 years then annually until death
PROJECTED ACCRUAL A total of 50-56 patients will be accrued for this study within 7 months
OUTLINE Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days for 6 weeks and cisplatin IV over 1-2 hours on days 1 and 22 Patients may undergo salvage surgery if biopsy proven cancer remains more than 3 months after treatment Patients are followed every 3 months for 2 years every 6 months for 3 years then annually until death
PROJECTED ACCRUAL A total of 50-56 patients will be accrued for this study within 7 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 |
|---|---|---|---|
| CDR0000067706 | None | None | None |