Pharynx CancerPhase 3NCT00359645
Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population
A Phase 3 study testing Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years in people with Pharynx Cancer and Larynx Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 35 sites in France.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharynx Cancer, Larynx Cancer, Oral Cavity Cancer
- What is being tested?
- Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,993 participants
- Where
- 35 sitesFrance
- Study dates
- 21 Jun 2006to 18 Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- current or previous heavy smokers (smoked >= 20 years) and alcohol drinkers who need specialized care
Who cannot join
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
France35 sites
Centre Hospitalier MONTPERRIN
Aix-en-Provence, 13100
CHIAB Annemasse Bonneville
Annemasse, 74 100
Centre Hospitalier d'ARRAS
Arras, 62000
CHS de L'Yonne
Auxerre, 89000
Chg Beziers
Béziers, 34525
C.A.S.A.
Clermont, 60600
CHU Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Centre Hospitalier de DIEPPE
Dieppe, 76200
CHU le Bocage
Dijon, 21034
Centre Hospitalier Louis Sevestre
La Membrolle-sur-Choisille, 37390
Centre Hospitalier du Mans
Le Mans, 72037
Centre Hospitalier de LENS
Lens, 62300
CHU de Lille
Lille, 59
CHBS Lorient
Lorient, 56322
Centre hospitalier Lyon sud
Lyon, 69
Centre Hospitalier des Chanaux
Mâcon, 71
CHU de Nancy
Nancy, 54035
CHU de Nantes
Nantes, 44
Hôpital ARCHET II
Nice, 06202
Centre ANPAA d'Orléans
Orléans, 45000
Centre Paul Cézanne
Orléans, 45000
Hôpital de la Source
Orléans, 45067
Clinique Philae
Pont-Péan, 35131
Centre Hospitalier du Centre Bretagne
Pontivy, 56306
Centre ANPAA 51 de Reims
Reims, 51100
CHU Hôpital Pontchaillou
Rennes, 35033
Hopital de Saint Cloud
Saint-Cloud, 92
CHR de la Réunion
Saint-denis de La Reunion, 97405
Ch Saint-Egreve
Saint-Égrève, 38521
Centre de soins de suite Marienbronn
Soultz-sous-Forêts, 67250
CHU de Strasbourg - Hôpital Hautepierre
Strasbourg, 67098
Hôpitaux du Leman
Thonon-les-Bains, 74200
Chba Vannes
Vannes, 56000
Hopital Paul Brousse
Villejuif, 94805
Institut_Gustave-Roussy
Villejuif, 94805
About this study
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.
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.
Read the 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%.
- Conditions
- Pharynx Cancer, Larynx Cancer, Oral Cavity Cancer, Oesophageal Cancer
- Being tested
- Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years
- Keywords
- Screening, Upper aerodigestive tract cancer, Alcohol, Tobacco, Randomized trial
- Medical subject headings
- Pharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 yearsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Annual auto questionnaire |
| Screening | Experimental | Annual screening of Head and Neck cancer Receives: Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper aerodigestive tract cancer mortality
Measured: 5 years
Secondary outcomes (3)
Screening test morbidity
Measured: 1 week
Upper aerodigestive tract cancer incidence
Measured: 5 years
Upper aerodigestive tract cancer stage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study start21 Jun 2006
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,993 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane TEMAM, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359645
- Sponsor's protocol ID
- DEPISTORL - THANCS
- Other IDs
- CET 1172
- Status last verified
- May 2017
- First submitted
- 1 Aug 2006
- Last updated
- 16 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00359645
- Acronym / sponsor ID
- DEPISTORL - THANCS
- Conditions
- Pharynx Cancer, Larynx Cancer, Oral Cavity Cancer, Oesophageal Cancer
- Keywords
- Screening, Upper aerodigestive tract cancer, Alcohol, Tobacco, Randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,993 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 21 Jun 2006 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 2 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Annual auto questionnaire |
| Screening | Experimental | Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 yearsAnnual screening of Head and Neck cancer |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- current or previous heavy smokers (smoked >= 20 years) and alcohol drinkers who need specialized care
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years | Procedure or surgery | Screening |
Primary outcome
Upper aerodigestive tract cancer mortality
Time frame: 5 years
3 secondary outcomes
Screening test morbidity
Time frame: 1 week
Upper aerodigestive tract cancer incidence
Time frame: 5 years
Upper aerodigestive tract cancer stage
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- DepistORLLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane TEMAM, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years in people with Pharynx Cancer and Larynx Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 35 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper aerodigestive tract cancer mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.