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

Phase 3

Completed

• Conditions: Oral Cavity Cancer; Oesophageal Cancer; Pharynx Cancer; Larynx Cancer
• Interventions: Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years

• Registration Number: NCT00359645
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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%.

Study Timeline

• Study Start: 2006-06-21
• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Primary Completion: 2015-12-18
• Study Completion: 2015-12-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1993

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening	Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years	Annual screening of Head and Neck cancer

Primary Outcome Measures

Name	Time	Method
Upper aerodigestive tract cancer mortality	5 years

Secondary Outcome Measures

Name	Time	Method
Upper aerodigestive tract cancer incidence	5 years
Upper aerodigestive tract cancer stage	5 years
Screening test morbidity	1 week

Trial Locations

Locations (35)

CHIAB Annemasse Bonneville; 🇫🇷 Annemasse, France

Centre Hospitalier MONTPERRIN; 🇫🇷 Aix en Provence, France

CHU Hôpital Gabriel Montpied; 🇫🇷 Clermont-ferrand, France

Centre Hospitalier d'ARRAS; 🇫🇷 Arras, France

CHS de L'Yonne; 🇫🇷 Auxerre, France

Centre Hospitalier de DIEPPE; 🇫🇷 Dieppe, France

Chg Beziers; 🇫🇷 Beziers, France

C.A.S.A.; 🇫🇷 Clermont, France

CHU le Bocage; 🇫🇷 Dijon, France

Centre Hospitalier du Mans; 🇫🇷 Le Mans, France

Centre Hospitalier Louis Sevestre; 🇫🇷 La Membrolle Sur Choisille, France

CHU de Lille; 🇫🇷 Lille, France

Centre Hospitalier de LENS; 🇫🇷 Lens, France

CHBS Lorient; 🇫🇷 Lorient, France

Centre Hospitalier des Chanaux; 🇫🇷 Macon, France

Centre hospitalier Lyon sud; 🇫🇷 Lyon, 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

Centre Hospitalier du Centre Bretagne; 🇫🇷 Pontivy, France

Clinique Philae; 🇫🇷 Pont Pean, France

CHU Hôpital Pontchaillou; 🇫🇷 Rennes, France

Centre ANPAA 51 de Reims; 🇫🇷 Reims, France

Hopital de Saint Cloud; 🇫🇷 Saint Cloud, France

CHR de la Réunion; 🇫🇷 Saint-denis de La Reunion, France

Hôpitaux du Leman; 🇫🇷 Thonon Les Bains, France

Centre de soins de suite Marienbronn; 🇫🇷 Soultz-sous-forets, France

Ch Saint-Egreve; 🇫🇷 Saint-egreve, France

CHU de Strasbourg - Hôpital Hautepierre; 🇫🇷 Strasbourg, France

Chba Vannes; 🇫🇷 Vannes, France

Hopital Paul Brousse; 🇫🇷 Villejuif, France

Institut_Gustave-Roussy; 🇫🇷 Villejuif, France