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NCT00359645 Clinical Trial

Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population

Oesophageal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00359645
Other study ID # DEPISTORL - THANCS
Secondary ID CET 1172
Status Completed
Phase Phase 3
First received August 1, 2006
Last updated May 15, 2017
Start date June 21, 2006
Est. completion date December 18, 2015

Study information
Verified date May 2017
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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%.

Recruitment information / eligibility
Status Completed
Enrollment 1993
Est. completion date December 18, 2015
Est. primary completion date December 18, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years

Locations
Country Name City State
France Centre Hospitalier MONTPERRIN Aix en Provence
France CHIAB Annemasse Bonneville Annemasse
France Centre Hospitalier d'ARRAS Arras
France CHS de L'Yonne Auxerre
France Chg Beziers Beziers
France C.A.S.A. Clermont
France CHU Hôpital Gabriel Montpied Clermont-ferrand
France Centre Hospitalier de DIEPPE Dieppe
France CHU le Bocage Dijon
France Centre Hospitalier Louis Sevestre La Membrolle Sur Choisille
France Centre Hospitalier du Mans Le Mans
France Centre Hospitalier de LENS Lens
France CHU de Lille Lille
France CHBS Lorient Lorient
France Centre hospitalier Lyon sud Lyon
France Centre Hospitalier des Chanaux Macon
France CHU de Nancy Nancy
France CHU de Nantes Nantes
France Hôpital ARCHET II Nice
France Centre ANPAA d'Orléans Orléans
France Centre Paul Cézanne Orléans
France Hôpital de la Source Orléans
France Clinique Philae Pont Pean
France Centre Hospitalier du Centre Bretagne Pontivy
France Centre ANPAA 51 de Reims Reims
France CHU Hôpital Pontchaillou Rennes
France Hopital de Saint Cloud Saint Cloud
France CHR de la Réunion Saint-denis de La Reunion
France Ch Saint-Egreve Saint-egreve
France Centre de soins de suite Marienbronn Soultz-sous-forets
France CHU de Strasbourg - Hôpital Hautepierre Strasbourg
France Hôpitaux du Leman Thonon Les Bains
France Chba Vannes Vannes
France Hopital Paul Brousse Villejuif
France Institut_Gustave-Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Upper aerodigestive tract cancer mortality 5 years
Secondary Screening test morbidity 1 week
Secondary Upper aerodigestive tract cancer incidence 5 years
Secondary Upper aerodigestive tract cancer stage 5 years
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