Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004226
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-01-28
Brief Title:
Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
Sponsor:
University of Alabama at Birmingham
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
Status:
UNKNOWN
Status Verified Date:
2004-07
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
PURPOSE Phase III trial to study the effectiveness of radiation therapy following surgery in treating patients who have recurrent or second primary cancer of the head and neck following previous radiation therapy
PURPOSE Phase III trial to study the effectiveness of radiation therapy following surgery in treating patients who have recurrent or second primary cancer of the head and neck following previous radiation therapy
Detailed Description:
OBJECTIVES
Determine the survival and local control in previously irradiated patients at high risk for local failure following regional resection of recurrent or second primary head and neck cancer
Determine the acute and late toxicities of this treatment in these patients
Determine the pattern of disease failure in these patients on this treatment
Determine any change in quality of life in these patients on this treatment
OUTLINE Patients receive fractionated doses of radiotherapy five times weekly for 6 weeks
Quality of life is assessed prior to study 2 months after radiotherapy every 3 months for remainder of year 1 every 4 months for years 2-3 every 6 months for years 4-5 and then annually thereafter
Patients are followed 2 months after radiotherapy every 3 months for year 1 every 4 months for year 2 every 6 months for years 3-5 and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 5 years
Determine the survival and local control in previously irradiated patients at high risk for local failure following regional resection of recurrent or second primary head and neck cancer
Determine the acute and late toxicities of this treatment in these patients
Determine the pattern of disease failure in these patients on this treatment
Determine any change in quality of life in these patients on this treatment
OUTLINE Patients receive fractionated doses of radiotherapy five times weekly for 6 weeks
Quality of life is assessed prior to study 2 months after radiotherapy every 3 months for remainder of year 1 every 4 months for years 2-3 every 6 months for years 4-5 and then annually thereafter
Patients are followed 2 months after radiotherapy every 3 months for year 1 every 4 months for year 2 every 6 months for years 3-5 and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| NCI-G99-1656 | None | None | None |
| UAB-RAD-9601 | None | None | None |
| UAB-F970430006 | None | None | None |