Laryngeal NeoplasmsNCT01257633
Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
An observational study of Laryngeal Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laryngeal Neoplasms
- What is being tested?
- Transoral robot-assisted tumor resection using the da Vinci robot
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2011to 30 Sep 2014
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is aimed at all patients with early stage (T1 or T2) glottic and / or supraglottic squamous cell carcinoma of the larynx, whatever their status and cervical lymph nodes without distant metastases (M0) and for whom endoscopic surgical treatment with robotic assistance is indicated following a multidisciplinary meeting.
Who may be able to join
- The subject has signed consent
- The subject must be a member or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The subject has a cancer of the larynx:
- classified T1 or T2 in the TNM
- glottic localization and / or supraglottic regardless of node status
Show all 9Show fewer
- with or without a history of head and neck cancer
- The subject does not have distant metastasis (M0)
- A decision for endoscopic robot-assisted surgery is retained in multidisciplinary meeting
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
About this study
Official title: Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.
- Conditions
- Laryngeal Neoplasms
- Being tested
- Transoral robot-assisted tumor resection using the da Vinci robot
- Keywords
- da Vinci surgical robot, laryngeal cancer
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral robot-assisted tumor resection using the da Vinci robotProcedure or surgery
Transoral robot-assisted tumor resection using the da Vinci robot
| Study group | Role | What they receive |
|---|---|---|
| The study population | Laryngeal cancer patients requiring surgical tumor resection. Receives: Procedure: Transoral robot-assisted tumor resection using the da Vinci robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors
Measured: 1 day
Secondary outcomes (7)
Time to prepare the surgical setting (min)
Measured: 1 day
Time necessary to dock the robot (min)
Measured: 1 day
Total surgical time (console time) (min)
Measured: 1 day
Intervention time taking into account cervical ganglions (min)
Measured: 1 day
Was a tracheotomy necessary? yes/no
Measured: 1 day
Presence / absence of bleeding complications
Measured: 1 day
Was a conversion to an open procedure necessary? yes/no
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startApr 2011
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Lallemant, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257633
- Sponsor's protocol ID
- AOI/2010/BL-01
- Other IDs
- 2010-A01190-39
- Status last verified
- Mar 2015
- First submitted
- 9 Dec 2010
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lallemant B, Moriniere S, Ceruse P, Lebalch M, Aubry K, Hans S, Dolivet G, Malard O, Bonduelle Q, Vergez S. Transoral robotic surgery for squamous cell carcinomas of the posterior pharyngeal wall. Eur Arch Otorhinolaryngol. 2017 Dec;274(12):4211-4216. doi: 10.1007/s00405-017-4771-9. Epub 2017 Oct 14.
PubMed 29032418
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
- ClinicalTrials.gov ID
- NCT01257633
- Acronym / sponsor ID
- AOI/2010/BL-01
- Conditions
- Laryngeal Neoplasms
- Keywords
- da Vinci surgical robot, laryngeal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 10 Dec 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.
The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Procedure: Transoral robot-assisted tumor resection using the da Vinci robotLaryngeal cancer patients requiring surgical tumor resection. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is aimed at all patients with early stage (T1 or T2) glottic and / or supraglottic squamous cell carcinoma of the larynx, whatever their status and cervical lymph nodes without distant metastases (M0) and for whom endoscopic surgical treatment with robotic assistance is indicated following a multidisciplinary meeting.
Key inclusion criteria (9 listed)
- The subject has signed consent
- The subject must be a member or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The subject has a cancer of the larynx:
- classified T1 or T2 in the TNM
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Transoral robot-assisted tumor resection using the da Vinci robotTransoral robot-assisted tumor resection using the da Vinci robot | Procedure or surgery | The study population |
Primary outcome
The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors
Time frame: 1 day
7 secondary outcomes
Time to prepare the surgical setting (min)
Time frame: 1 day
Time necessary to dock the robot (min)
Time frame: 1 day
Total surgical time (console time) (min)
Time frame: 1 day
Intervention time taking into account cervical ganglions (min)
Time frame: 1 day
Was a tracheotomy necessary? yes/no
Time frame: 1 day
Presence / absence of bleeding complications
Time frame: 1 day
Was a conversion to an open procedure necessary? yes/no
Time frame: 1 day
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 17 Nov 2025.
- Results publication: PubMed 29032418Lallemant B, Moriniere S, Ceruse P, Lebalch M, Aubry K, Hans S, Dolivet G, Malard O, Bonduelle Q, Vergez S. Transoral robotic surgery for squamous cell carcinomas of the posterior pharyngeal wall. Eur Arch Otorhinolaryngol. 2017 Dec;274(12):4211-4216. doi: 10.1007/s00405-017-4771-9. Epub 2017 Oct 14.
Related trials for Laryngeal Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
RecruitingEarly Phase 1
PET/CT Assessment of Radiation-Induced Vascular Complications in Head and Neck Cancer
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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.
Benjamin Lallemant, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 3 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 9 inclusion and 1 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors (time frame: 1 day). 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 NCT01257633, which also lists 1 linked publication.
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 17 Nov 2025.