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
• 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

Related Conditions & MeSH terms

• Laryngeal Neoplasms
• Larynx Cancer
• Mouth Neoplasms
• Oesophageal Cancer
• Oral Cavity Cancer
• Pharyngeal Neoplasms
• Pharynx Cancer

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

External Links

•   DepistORL
•   Société Française d'Alcoologie