Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002727
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
Status:
COMPLETED
Status Verified Date:
2016-12
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 It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord
PURPOSE Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord
PURPOSE Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord
Detailed Description:
OBJECTIVES
Compare the local response rate in patients with stage II invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy
Compare the acute and late toxic effects of these regimens in this patient population
Compare the overall and disease-free survival patterns in this patient population treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to substage T2a vs T2b Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks
Arm II Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 16 weeks
Patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection at the discretion of the surgeon
Patients are followed at 4 weeks every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 240 patients will be accrued for this study within 32 years
Compare the local response rate in patients with stage II invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy
Compare the acute and late toxic effects of these regimens in this patient population
Compare the overall and disease-free survival patterns in this patient population treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to substage T2a vs T2b Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks
Arm II Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 16 weeks
Patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection at the discretion of the surgeon
Patients are followed at 4 weeks every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 240 patients will be accrued for this study within 32 years
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 |
|---|---|---|---|
| CDR0000064597 | None | None | None |