Lung NeoplasmPhase 4SPOCNCT01064050

Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers

A Phase 4 study testing silicone trachea-bronchial stent Dumon (Novatech) in people with Lung Neoplasm and Carcinoma, Non-Small-Cell Lung, run by Centre Hospitalier Universitaire de Saint Etienne at 13 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Neoplasm, Carcinoma, Non-Small-Cell Lung
What is being tested?: silicone trachea-bronchial stent Dumon (Novatech)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 13 sitesFrance
Study dates: Nov 2008to May 2012
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

> 18 years
non-small cell lung cancer,
inoperable and location : tracheal, carinal, main bronchus right or left, or intermediate trunk.
TNM stage known and oncological treatment later determined
central initial intrinsic bronchial obstruction > 50%.
resection of tumor with endoscopy, to obtain after therapeutic bronchoscopy a diameter > 50% normal diameter of bronchial segment achieved.

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Tumoral segment fully recoverable by a stent
Written consent, free and informed
Patient affiliated or who is entitled to to a social security scheme.

Who cannot join

against-indication for general anesthesia.
Patient with one lung not working beyond the stenosis
Patient under guardianship
Pregnancy
12 months follow-up impossible

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

France13 sites

Department of pneumology, CHU Amiens
Amiens
Departement of pneumology, CHU Brest
Brest
Pneumology departement, Hôpital Percy
Clamart
Pneumology departement, CHRU Lille
Lille
Pneumology departement, CHU Limoges
Limoges
Pneumology departement, Sainte Marguerite hospital
Marseille
Pneumology departement, CHU Nantes
Nantes
Pneumology departement, Saint-Antoine hospital
Paris
Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims
Reims
Pneumology Clinic - Albert Calmette hospital- CHU Rouen
Rouen
Pneumology departement CHU Saint-Etienne
Saint-Etienne, 42055
Endoscopy unit, Thoracic surgery department, Foch Hospital
Suresnes
Departement of pneumology, CHU TOULOUSE
Toulouse

Other trials in France

About this study

Official title: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)

The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.

Conditions: Lung Neoplasm, Carcinoma, Non-Small-Cell Lung
Being tested: silicone trachea-bronchial stent Dumon (Novatech)
Keywords: tumoral obstruction of the main stem bronchus, bronchoscopy, silicone stent
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

silicone trachea-bronchial stent Dumon (Novatech)Device
Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area

Study groups in NCT01064050
Study group	Role	What they receive
trachea-bronchial stent (Novatech)	Experimental	Not described Receives: Device: silicone trachea-bronchial stent Dumon (Novatech)
control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)
Measured: 12 months

Secondary outcomes (4)

death
Measured: 12 months
For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months.
Measured: 12 months
Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy.
Measured: 12 months
Quality of life : EORTC
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008May 2012

First posted8 Feb 2010 (estimated)
Study startNov 2008
Primary completionMay 2012
Study completionMay 2012

Why it stopped: Difficulty to include patient

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung NeoplasmStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01064050
Sponsor's protocol ID: 0708042
Other IDs: 2007-A01190-53
Acronym: SPOC
Status last verified: Jul 2015
First submitted: 2 Feb 2010
Last updated: 28 Jul 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)
ClinicalTrials.gov ID: NCT01064050
Acronym / sponsor ID: SPOC / 0708042
Conditions: Lung Neoplasm, Carcinoma, Non-Small-Cell Lung
Keywords: tumoral obstruction of the main stem bronchus, bronchoscopy, silicone stent
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty to include patient
Enrolment: 75 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Collaborators: Ministry of Health, France, Ligue contre le cancer, France
Study start: Nov 2008
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 8 Feb 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
trachea-bronchial stent (Novatech)	Experimental	Device: silicone trachea-bronchial stent Dumon (Novatech)
control	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

> 18 years
non-small cell lung cancer,
inoperable and location : tracheal, carinal, main bronchus right or left, or intermediate trunk.
TNM stage known and oncological treatment later determined
central initial intrinsic bronchial obstruction > 50%.

Key exclusion criteria (5 listed)

against-indication for general anesthesia.
Patient with one lung not working beyond the stenosis
Patient under guardianship
Pregnancy
12 months follow-up impossible

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
silicone trachea-bronchial stent Dumon (Novatech)Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area	Device	trachea-bronchial stent (Novatech)

Primary outcome

Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)
Time frame: 12 months

4 secondary outcomes

death
Time frame: 12 months
For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months.
Time frame: 12 months
Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy.
Time frame: 12 months
Quality of life : EORTC
Time frame: 12 months

Results and safety

The study was stopped early (reason given: Difficulty to include patient). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.

Related trials for Lung Neoplasm

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Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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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.

Jean-Michel Vergnon, MD PhD principal investigator

Centre Hospitalier Universitaire de Saint Etienne

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early (reason given: Difficulty to include patient). Results are not available in the source record.

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?

Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01064050.

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 28 Jul 2015.