Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021125
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-07-11
Brief Title:
Radiation Therapy in Treating Patients With Head and Neck Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Controlled Trial Of CHARTWEL a Continuous Hyperfractionated Accelerated Radiotherapy Schedule Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients
Status:
COMPLETED
Status Verified Date:
2002-12
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 regimen of radiation therapy is more effective for head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer
Detailed Description:
OBJECTIVES
Compare adjuvant continuous hyperfractionated accelerated radiotherapy vs conventional radiotherapy in terms of preventing disease recurrence in patients with head and neck cancer
Compare the early and late toxic effects of these treatments in this patient population
Compare disease-free and overall survival of patients receiving these treatments
Assess quality of life in patients receiving these treatments
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy 3 times daily with an interval of at least 6 hours between any 2 treatments 5 days a week for just over 2 weeks for a total of 13-14 treatment days
Arm II Patients undergo radiotherapy daily 5 days a week for 6-65 weeks Quality of life is assessed at baseline and then annually for 5 years
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 460 patients 230 per arm will be accrued for this study within 2-3 years
Compare adjuvant continuous hyperfractionated accelerated radiotherapy vs conventional radiotherapy in terms of preventing disease recurrence in patients with head and neck cancer
Compare the early and late toxic effects of these treatments in this patient population
Compare disease-free and overall survival of patients receiving these treatments
Assess quality of life in patients receiving these treatments
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy 3 times daily with an interval of at least 6 hours between any 2 treatments 5 days a week for just over 2 weeks for a total of 13-14 treatment days
Arm II Patients undergo radiotherapy daily 5 days a week for 6-65 weeks Quality of life is assessed at baseline and then annually for 5 years
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 460 patients 230 per arm will be accrued for this study within 2-3 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 |
|---|---|---|---|
| ISRCTN62576956 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068750 | REGISTRY | None | None |
| EU-20121 | None | None | None |