Neck CancerNCT05746780
Bilateral Elective Neck Dissection in Salvage Total Laryngectomy
An observational study of Neck Cancer and Larynx, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neck Cancer, Larynx, Larynx Cancer
- What is being tested?
- Elective bilateral neck dissection in cN0 patients
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 1 Mar 2021
- 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: Patient affected by recurrent laryngeal cancer, after failure of primary radiotherapy or conservative surgery, with clinically negative neck (cN0) and treated with salvage total laryngectomy and concomitant elective selective bilateral neck dissection (levels II-IV + VI).
Who may be able to join
- -patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI).
Who cannot join
- patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Value and Prognostic Impact of Bilateral Elective Neck Dissection in Salvage Total Laryngectomy of cN0 Cases
The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.
- Conditions
- Neck Cancer, Larynx, Larynx Cancer, Neck
- Being tested
- Elective bilateral neck dissection in cN0 patients
- Keywords
- neck dissection, SALVAGE TOTAL LARYNGECTOMY
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Diseases, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective bilateral neck dissection in cN0 patientsProcedure or surgery
Radical modified type 3 selective bilaterale elective neck dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
Occult lymph node metastasis
Incidence rate of occult lymph node metastasislaryngectomy with clinically negative lymph nodes (cN0), estimating the prevalence of histologically positive lymph nodes (pN+) and predictive factors for cervical lymph nodes metastasis
Measured: At the time of salvage surgery
Secondary outcomes (3)
Complications of bilateral neck dissection during hospitalization
Complications of bilateral neck dissection during hospitalization
Measured: Up to 15 days from salvage surgery
Overall survival
Survival of the patient from any disease
Measured: 5 year
Disease specific survival
Survival of the patient from laryngeal disease
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 posted28 Feb 2023
- Study start1 Sep 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galli Jacopo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746780
- Sponsor's protocol ID
- 3364
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value and Prognostic Impact of Bilateral Elective Neck Dissection in Salvage Total Laryngectomy of cN0 Cases
- ClinicalTrials.gov ID
- NCT05746780
- Acronym / sponsor ID
- 3364
- Conditions
- Neck Cancer, Larynx, Larynx Cancer, Neck
- Keywords
- neck dissection, SALVAGE TOTAL LARYNGECTOMY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Feb 2023 (actual)
- 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 aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient affected by recurrent laryngeal cancer, after failure of primary radiotherapy or conservative surgery, with clinically negative neck (cN0) and treated with salvage total laryngectomy and concomitant elective selective bilateral neck dissection (levels II-IV + VI).
Key inclusion criteria (1 listed)
- -patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI).
Key exclusion criteria (1 listed)
- patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.
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 |
|---|---|---|
| Elective bilateral neck dissection in cN0 patientsRadical modified type 3 selective bilaterale elective neck dissection | Procedure or surgery | – |
Primary outcome
Occult lymph node metastasis
Time frame: At the time of salvage surgery
Incidence rate of occult lymph node metastasislaryngectomy with clinically negative lymph nodes (cN0), estimating the prevalence of histologically positive lymph nodes (pN+) and predictive factors for cervical lymph nodes metastasis
3 secondary outcomes
Complications of bilateral neck dissection during hospitalization
Time frame: Up to 15 days from salvage surgery
Overall survival
Time frame: 5 year
Disease specific survival
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 28 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Cancer and Larynx, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Occult lymph node metastasis (time frame: At the time of salvage surgery). 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 28 Feb 2023.