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Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population
This study is currently recruiting participants.
Verified March 2011 by Institut Gustave Roussy

First Received on August 1, 2006.   Last Updated on March 31, 2011   History of Changes
Sponsor: Institut Gustave Roussy
Information provided by: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00359645
  Purpose

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
Malignant Neoplasm of Esophagus
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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Upper aerodigestive tract cancer mortality

Secondary Outcome Measures:
  • Screening test morbidity
  • Upper aerodigestive tract cancer incidence
  • Upper aerodigestive tract cancer stage

Estimated Enrollment: 20000
Study Start Date: August 2006
Detailed Description:

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%.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • current or previous heavy smokers (smoked >= 20 years) and alcohol drinkers who need specialized care

Exclusion Criteria:

  • Head and neck clinical examination during the past 6 months
  • History of squamous cell carcinoma of the upper aero-digestive tract.
  • Recent digestive hemorrhage from varicose esophagus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359645

Contacts
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

Locations
France
Centre Hospitalier MONTPERRIN Recruiting
Aix en Provence, France, 13100
Contact: Gilda REVEL            
CHIAB Annemasse Bonneville Recruiting
Annemasse, France, 74 100
Contact: Chantal LATTARD            
Centre Hospitalier d'ARRAS Recruiting
Arras, France, 62000
Contact: Damien DUQUESNE            
CHS de L'Yonne Recruiting
Auxerre, France, 89000
Contact: Michel THUILIER            
Chg Beziers Recruiting
Beziers, France, 34525
Contact: Olivier DUHAMEL            
C.A.S.A. Recruiting
Clermont, France, 60600
Contact: Sophie VELASTEGUI            
CHU Hôpital Gabriel Montpied Recruiting
Clermont-ferrand, France, 63003
Contact: François PLANCHE            
Centre Hospitalier de DIEPPE Recruiting
Dieppe, France, 76200
Contact: Nathalie VIGE            
CHU le Bocage Recruiting
Dijon, France, 21034
Contact: Laurent BEDENNE            
Centre Hospitalier Louis Sevestre Recruiting
La Membrolle Sur Choisille, France, 37390
Contact: Marion HUSSON            
Centre Hospitalier du Mans Recruiting
Le Mans, France, 72037
Contact: Marie Hélène POIRIER-GARCIA            
Centre Hospitalier de LENS Recruiting
Lens, France, 62300
Contact: Emmanuel Brunelle            
CHU de Lille Recruiting
Lille, France, 59
Contact: Olivier COTTENCIN, MD            
CHBS Lorient Recruiting
Lorient, France, 56322
Contact: Gilles GUIDON            
Centre hospitalier Lyon sud Recruiting
Lyon, France, 69
Contact: Claude AUGUSTIN-NORMAND            
Centre Hospitalier des Chanaux Recruiting
Macon, France, 71
Contact: Pascal MENECIER            
CHU de Nancy Recruiting
Nancy, France, 54035
Contact: Hervé MARTINI, MD     00 33 (0)38-385-2421     h.martini@chu-nancy.fr    
CHU de Nantes Recruiting
Nantes, France, 44
Contact: Marie BRONNEC            
Hôpital ARCHET II Recruiting
Nice, France, 06202
Contact: Eve GELSI            
Centre ANPAA d'Orléans Recruiting
Orléans, France, 45000
Contact: Muriel BOIN-CORBELLA            
Hôpital de la Source Recruiting
Orléans, France, 45067
Contact: Damien LABARRIERE            
Centre Paul Cézanne Recruiting
Orléans, France, 45000
Contact: Azeb SEBATLAB            
Clinique Philae Recruiting
Pont Pean, France, 35131
Contact: André DENOUAL            
Centre Hospitalier du Centre Bretagne Recruiting
Pontivy, France, 56306
Contact: Jacques-Arnaud SEYRIG            
Centre ANPAA 51 de Reims Recruiting
Reims, France, 51100
Contact: Claire MASURE            
CHU Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: Romain MOIRAND            
Hopital de Saint Cloud Active, not recruiting
Saint Cloud, France, 92
CHR de la Réunion Recruiting
Saint-denis de La Reunion, France, 97405
Contact: David METE            
Ch Saint-Egreve Recruiting
Saint-egreve, France, 38521
Contact: Jean BOURGADE            
Centre de soins de suite Marienbronn Recruiting
Soultz-sous-forets, France, 67250
Contact: Daniel BROBECK            
CHU de Strasbourg - Hôpital Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Laurence CAUMONT            
Hôpitaux du Leman Recruiting
Thonon Les Bains, France, 74200
Contact: Muriel ROUGE            
Chba Vannes Recruiting
Vannes, France, 56000
Contact: Nadine POURTOUT            
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    
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Stéphane TEMAM, PhD Institut Gustave Roussy
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00359645     History of Changes
Other Study ID Numbers: DEPISTORL - THANCS, CET 1172
Study First Received: August 1, 2006
Last Updated: March 31, 2011
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:
Screening
Upper aerodigestive tract cancer
Alcohol
Tobacco
Randomized trial

Additional relevant MeSH terms:
Neoplasms
Laryngeal Neoplasms
Esophageal Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on February 12, 2012