Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147732
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2005-09-06
Brief Title:
Randomized Trial of ARCON in Larynx Cancer
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
A Multicentre Randomised Phase III Clinical Trial Comparing Accelerated Radiotherapy With Accelerated Radiotherapy Plus Carbogen and Nicotinamide ARCON in Clinical Stage T2-4 Laryngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-05
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:
TITLE
A multicentre randomised phase III clinical trial comparing accelerated radiotherapy with accelerated radiotherapy plus carbogen and nicotinamide ARCON in clinical stage T2-4 laryngeal carcinoma
PRIMARY OBJECTIVE
Does the addition of carbogen and nicotinamide to a schedule of accelerated radiotherapy in patients with clinical stage T2-4 laryngeal carcinoma improve local primary tumour control Definitive analysis will be performed on local control rates at two years after completion of radiotherapy
SECONDARY OBJECTIVES
Does the addition of carbogen and nicotinamide
increase the larynx preservation rate
increase the regional control rate
increase the toxicity of accelerated radiotherapy
improve the overall quality of life
improve the disease-free survival
improve the overall survival
STUDY DESIGN
An open-label randomised clinical trial assigning patients in a 11 ratio to one of the following treatment arms
accelerated radiotherapy
accelerated radiotherapy plus carbogen and nicotinamide
PATIENT CHARACTERISTICS AND NUMBER
344 patients with clinical T2-4 laryngeal carcinoma
MEASUREMENTS
time to local failure
time to regional failure
survival with functional larynx
overall and disease-free survival
frequency and severity of complications related to radiotherapy and carbogen and nicotinamide
quality of life assessment
A multicentre randomised phase III clinical trial comparing accelerated radiotherapy with accelerated radiotherapy plus carbogen and nicotinamide ARCON in clinical stage T2-4 laryngeal carcinoma
PRIMARY OBJECTIVE
Does the addition of carbogen and nicotinamide to a schedule of accelerated radiotherapy in patients with clinical stage T2-4 laryngeal carcinoma improve local primary tumour control Definitive analysis will be performed on local control rates at two years after completion of radiotherapy
SECONDARY OBJECTIVES
Does the addition of carbogen and nicotinamide
increase the larynx preservation rate
increase the regional control rate
increase the toxicity of accelerated radiotherapy
improve the overall quality of life
improve the disease-free survival
improve the overall survival
STUDY DESIGN
An open-label randomised clinical trial assigning patients in a 11 ratio to one of the following treatment arms
accelerated radiotherapy
accelerated radiotherapy plus carbogen and nicotinamide
PATIENT CHARACTERISTICS AND NUMBER
344 patients with clinical T2-4 laryngeal carcinoma
MEASUREMENTS
time to local failure
time to regional failure
survival with functional larynx
overall and disease-free survival
frequency and severity of complications related to radiotherapy and carbogen and nicotinamide
quality of life assessment
Detailed Description:
None
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 |
|---|---|---|---|
| CKTO 2000-09 | None | None | None |