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

This study has been terminated.
(Too low accrual)
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00359645
First received: August 1, 2006
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Pharynx Cancer
Larynx Cancer
Oral Cavity Cancer
Oesophageal Cancer
Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Upper aerodigestive tract cancer mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Screening test morbidity [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Upper aerodigestive tract cancer incidence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Upper aerodigestive tract cancer stage [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1993
Study Start Date: August 2006
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359645

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

Additional Information:
No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00359645     History of Changes
Other Study ID Numbers: DEPISTORL - THANCS, CET 1172
Study First Received: August 1, 2006
Last Updated: March 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Screening
Upper aerodigestive tract cancer
Alcohol
Tobacco
Randomized trial

Additional relevant MeSH terms:
Laryngeal Neoplasms
Esophageal Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on April 23, 2014