Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00359645
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact
Status Completed
Phase Phase 3
Start date June 21, 2006
Completion date December 18, 2015

See also
  Status Clinical Trial Phase
Recruiting NCT05685862 - Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit
Recruiting NCT01795768 - Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours Phase 2
Completed NCT05266300 - Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
Recruiting NCT03978377 - Cardiopulmonary Toxicity of Thoracic Radiotherapy
Active, not recruiting NCT03653052 - Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab Phase 2
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Recruiting NCT05489250 - The PLATON Network
Terminated NCT01795976 - NY-ESO-1 T Cells in OG Cancer Phase 2
Recruiting NCT01843829 - A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer Phase 2
Completed NCT01915693 - ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study Phase 3
Completed NCT02382237 - Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition N/A
Recruiting NCT04517448 - Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
Recruiting NCT04232735 - Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE) N/A
Recruiting NCT05642819 - REVOLUTION Surgery (REVOLUTION Surgery)
Recruiting NCT04001478 - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Recruiting NCT02741856 - Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation Phase 2/Phase 3
Not yet recruiting NCT05600608 - Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome N/A
Recruiting NCT04481256 - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY N/A
Recruiting NCT05057013 - HMBD-001 in Advanced HER3 Positive Solid Tumours Phase 1/Phase 2
Not yet recruiting NCT06046846 - Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer N/A