Clinical trial NCT00359645: Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharynx Cancer
Larynx Cancer
Oral Cavity Cancer
Oesophageal Cancer
Keywords: Screening
Upper aerodigestive tract cancer
Alcohol
Tobacco
Randomized trial
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2006-08-02
Enrollment: 1993
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Upper aerodigestive tract cancer mortality
timeFrame: 5 years
Secondary outcomes:
measure: Screening test morbidity
timeFrame: 1 week
measure: Upper aerodigestive tract cancer incidence
timeFrame: 5 years
measure: Upper aerodigestive tract cancer stage
timeFrame: 5 years
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier MONTPERRIN
city: Annemasse
country: France
facility: CHIAB Annemasse Bonneville
city: Arras
country: France
facility: Centre Hospitalier d'ARRAS
city: Auxerre
country: France
facility: CHS de L'Yonne
city: Beziers
country: France
facility: Chg Beziers
city: Clermont-ferrand
country: France
facility: CHU Hôpital Gabriel Montpied
city: Clermont
country: France
facility: C.A.S.A.
city: Dieppe
country: France
facility: Centre Hospitalier de DIEPPE
city: Dijon
country: France
facility: CHU le Bocage
city: La Membrolle Sur Choisille
country: France
facility: Centre Hospitalier Louis Sevestre
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lens
country: France
facility: Centre Hospitalier de LENS
city: Lille
country: France
facility: CHU de Lille
city: Lorient
country: France
facility: CHBS Lorient
city: Lyon
country: France
facility: Centre hospitalier Lyon sud
city: Macon
country: France
facility: Centre Hospitalier des Chanaux
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: Hôpital ARCHET II
city: Orléans
country: France
facility: Centre ANPAA d'Orléans
city: Orléans
country: France
facility: Centre Paul Cézanne
city: Orléans
country: France
facility: Hôpital de la Source
city: Pont Pean
country: France
facility: Clinique Philae
city: Pontivy
country: France
facility: Centre Hospitalier du Centre Bretagne
city: Reims
country: France
facility: Centre ANPAA 51 de Reims
city: Rennes
country: France
facility: CHU Hôpital Pontchaillou
city: Saint Cloud
country: France
facility: Hopital de Saint Cloud
city: Saint-denis de La Reunion
country: France
facility: CHR de la Réunion
city: Saint-egreve
country: France
facility: Ch Saint-Egreve
city: Soultz-sous-forets
country: France
facility: Centre de soins de suite Marienbronn
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital Hautepierre
city: Thonon Les Bains
country: France
facility: Hôpitaux du Leman
city: Vannes
country: France
facility: Chba Vannes
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Villejuif
country: France
facility: Institut_Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Stéphane TEMAM, PhD
role: PRINCIPAL_INVESTIGATOR
References: