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

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.

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 Overview

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

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 Type: Interventional
• Enrollment (Actual): 1993
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13100
    • Centre Hospitalier MONTPERRIN
  • Annemasse, France, 74 100
    • CHIAB Annemasse Bonneville
  • Arras, France, 62000
    • Centre Hospitalier D'arras
  • Auxerre, France, 89000
    • CHS de L'Yonne
  • Beziers, France, 34525
    • Chg Beziers
  • Clermont, France, 60600
    • C.A.S.A.
  • Clermont-ferrand, France, 63003
    • CHU Hôpital Gabriel Montpied
  • Dieppe, France, 76200
    • Centre Hospitalier de Dieppe
  • Dijon, France, 21034
    • CHU Le Bocage
  • La Membrolle Sur Choisille, France, 37390
    • Centre Hospitalier Louis Sevestre
  • Le Mans, France, 72037
    • Centre Hospitalier du Mans
  • Lens, France, 62300
    • Centre Hospitalier de LENS
  • Lille, France, 59
    • CHU de Lille
  • Lorient, France, 56322
    • CHBS Lorient
  • Lyon, France, 69
    • Centre Hospitalier Lyon Sud
  • Macon, France, 71
    • Centre Hospitalier des Chanaux
  • Nancy, France, 54035
    • Chu de Nancy
  • Nantes, France, 44
    • CHU de Nantes
  • Nice, France, 06202
    • Hôpital ARCHET II
  • Orléans, France, 45067
    • Hôpital de la Source
  • Orléans, France, 45000
    • Centre ANPAA d'Orléans
  • Orléans, France, 45000
    • Centre Paul Cézanne
  • Pont Pean, France, 35131
    • Clinique Philae
  • Pontivy, France, 56306
    • Centre Hospitalier du Centre Bretagne
  • Reims, France, 51100
    • Centre ANPAA 51 de Reims
  • Rennes, France, 35033
    • CHU Hôpital Pontchaillou
  • Saint Cloud, France, 92
    • Hopital de Saint Cloud
  • Saint-denis de La Reunion, France, 97405
    • CHR de la Réunion
  • Saint-egreve, France, 38521
    • Ch Saint-Egreve
  • Soultz-sous-forets, France, 67250
    • Centre de soins de suite Marienbronn
  • Strasbourg, France, 67098
    • CHU de Strasbourg - Hôpital Hautepierre
  • Thonon Les Bains, France, 74200
    • Hôpitaux du Léman
  • Vannes, France, 56000
    • CHBA Vannes
  • Villejuif, France, 94805
    • Hopital Paul Brousse
  • Villejuif, France, 94805
    • Institut_Gustave-Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Annual auto questionnaire
EXPERIMENTAL: Screening; Annual screening of Head and Neck cancer	Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Upper aerodigestive tract cancer mortality	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Screening test morbidity	1 week
Upper aerodigestive tract cancer incidence	5 years
Upper aerodigestive tract cancer stage	5 years

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Principal Investigator: Stéphane TEMAM, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

Helpful Links

• Société Française d'Alcoologie

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2006
• Primary Completion (ACTUAL): December 18, 2015
• Study Completion (ACTUAL): December 18, 2015

Study Registration Dates

• First Submitted: August 1, 2006
• First Submitted That Met QC Criteria: August 1, 2006
• First Posted (ESTIMATE): August 2, 2006

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Screening; Tobacco; Alcohol; Randomized trial; Upper aerodigestive tract cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Laryngeal Diseases; Mouth Neoplasms; Laryngeal Neoplasms; Pharyngeal Neoplasms
• Other Study ID Numbers: DEPISTORL - THANCS; CET 1172