Trial Information

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.

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%.