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Sponsors and Collaborators: |
Radboud University Dutch Cancer Society |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00147732 |
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
STUDY DESIGN:
An open-label, randomised clinical trial assigning patients in a 1:1 ratio to one of the following treatment arms:
PATIENT CHARACTERISTICS AND NUMBER:
344 patients with clinical T2-4 laryngeal carcinoma
MEASUREMENTS:
Condition | Intervention | Phase |
---|---|---|
Larynx Carcinoma |
Radiation: Accelerated radiotherapy Radiation: ARCON |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 344 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | February 2013 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Accelerated radiotherapy
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Radiation: Accelerated radiotherapy
68 Gy over 5.5 weeks
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2: Experimental
ARCON
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Radiation: ARCON
68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Radboud University Nijmegen Medical Centre | |
Nijmegen, Netherlands, 6500 HB | |
University Medical centre Utrecht | |
Utrecht, Netherlands | |
University Medical Centre Groningen | |
Groningen, Netherlands | |
Leids University Medical Centre | |
Leiden, Netherlands | |
Maastro Clinic | |
Maastricht, Netherlands | |
Free University Medical Centre | |
Amsterdam, Netherlands | |
United Kingdom, Middlesex | |
Mount Vernon Hospital | |
Northwood, Middlesex, United Kingdom |
Principal Investigator: | Johannes HA Kaanders, MD, PhD | Radboud University |
Responsible Party: | Radboud University Medical Centre ( Prof. J. Kaanders ) |
Study ID Numbers: | 098, CKTO 2000-09 |
Study First Received: | September 6, 2005 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00147732 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
larynx carcinoma radiotherapy carbogen nicotinamide |
Antimetabolites Vasodilator Agents Vitamin B Complex Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Niacinamide Carbogen Laryngeal Carcinoma Antilipemic Agents Trace Elements Laryngeal Neoplasms Cardiovascular Agents |
Carcinoma Nicotinamide Nicotinic Acids Vitamin B3 Respiratory Tract Diseases Vitamins Head and Neck Neoplasms Micronutrients Laryngeal Diseases Nicotinic Acid Niacin Neoplasms, Glandular and Epithelial |
Antimetabolites Vasodilator Agents Otorhinolaryngologic Neoplasms Niacinamide Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nicotinic Acids Neoplasms by Site Respiratory Tract Diseases Therapeutic Uses Vitamins Laryngeal Diseases Micronutrients Respiratory Tract Neoplasms |
Otorhinolaryngologic Diseases Neoplasms by Histologic Type Vitamin B Complex Growth Substances Antilipemic Agents Laryngeal Neoplasms Cardiovascular Agents Pharmacologic Actions Carcinoma Neoplasms Head and Neck Neoplasms Niacin Neoplasms, Glandular and Epithelial |