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Sponsored by: |
Institut Gustave Roussy |
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Information provided by: | Institut Gustave Roussy |
ClinicalTrials.gov Identifier: | NCT00359645 |
Randomized multicenter trial to assess the impact of a screening program for heavy alcohol drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer mortality.
Condition | Intervention | Phase |
---|---|---|
Pharynx Cancer Larynx Cancer Oral Cavity Cancer Oesophageal Cancer |
Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | DEPISTORL - THANCS (Trial of Head And Neck Cancer Screening) Randomized Multicenter Trial to Assess the Impact of a Screening Program for Heavy Alcohol Drinkers and Smokers Treated in Alcohol Addiction Clinics on Upper Aerodigestive Tract Cancer Mortality. |
Estimated Enrollment: | 20000 |
Study Start Date: | August 2006 |
Upper aerodigestive tract (UADT) carcinomas (oral cavity and pharynx (63%), larynx (17%) and esophagus (20%)), are frequent in France with 25.000 new cases annually estimated in 2000, representing 13% of men cancer (3rd rank). Five-year specific survival rate is approximately 50% (11.000 deaths per year) and has not improved in over three decades, primarily due to the advanced stage at presentation. UADT cancers are also associated with profound disease- and treatment-related morbidity, with alterations in speech and feeding functions, aesthetic disability, with familial and social consequences.
The high-risk population is well characterized. A synergistic effect of tobacco smoking and alcohol drinking increases the risk of developing a carcinoma by more than 100 fold. Each year, 30.000 alcohol drinkers are treated in alcohol addiction clinics and could benefit from cancer detection. Nonrandomized pilot studies have showed that a UADT cancers screening trial could be undertaken in these clinics.
Study design: prospective randomized trial comparing an observation group and a screening group. Subjects in the screening group will undergo annual screening test including head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy with cytological examination during a 3-years period. In case of a positive test, patients will undergo head and neck panendoscopy and/or digestive flexible endoscopy and/or biopsy. After the screening period, subjects will be followed during 2 additional years by annual health questionnaires. Subjects of the observation group will be followed during 5 years by annual health questionnaires. Recruitment will be performed in alcohol addiction clinics and screening tests and confirmation exams in the closest specialized head and neck clinics.
The primary objective is to demonstrate a decrease in the UADT cancer mortality after a screening strategy, including head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy with cytological examination repeated annually during 3 years. Subjects will be followed during 5 years. A sample size of 10.000 subjects in each group allows the detection of a 33% reduction in the specific mortality rate, with a power of 80% and with a one sided a-risk of 5%.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stéphane TEMAM, PhD | 00 33 (0)14-211-4617 | temam@igr.fr |
Contact: Anne AUPERIN, MD | 00 33(0)14-211-5499 | auperin@igr.fr |
France | |
Institut_Gustave-Roussy | Recruiting |
Villejuif, France, 94805 | |
Contact: Stéphane TEMAM, PhD 00 33 (0)14-211-4617 temam@igr.fr | |
Hopital Paul Brousse | Recruiting |
Villejuif, France, 94805 | |
Contact: Laurent KARILA, MD 00 33 (0)14-559-3087 laurent.karila@pbr.aphp.fr | |
CHU de Nancy | Recruiting |
Nancy, France, 54035 | |
Contact: Hervé MARTINI, MD 00 33 (0)38-385-2421 h.martini@chu-nancy.fr | |
Hopital de Saint Cloud | Recruiting |
Saint Cloud, France, 92 | |
Contact: GEIGER-BOICHOT, MD | |
CHU de Lille | Not yet recruiting |
Lille, France, 59 | |
Contact: DANEL, MD |
Principal Investigator: | Stéphane TEMAM, PhD | Institut Gustave Roussy |
Study ID Numbers: | DEPISTORL - THANCS, CET 1172 |
Study First Received: | August 1, 2006 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00359645 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Screening Upper aerodigestive tract cancer Alcohol Tobacco Randomized trial |
Behavior, Addictive Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Pharyngeal Neoplasms Laryngeal Neoplasms Pharyngeal Diseases Digestive System Diseases |
Respiratory Tract Diseases Head and Neck Neoplasms Alcoholism Laryngeal carcinoma Gastrointestinal Neoplasms Stomatognathic Diseases Esophageal Diseases Laryngeal Diseases Esophageal neoplasm Ethanol |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |