Larynx CarcinomaNCT06287034
The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)
An observational study of Larynx Carcinoma, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Carcinoma
- What is being tested?
- Primary suture
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2023to 21 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients suffering from recurrence/persistence of laryngeal SCC following exclusive RT treatment or concomitant RT/ChT without extension to the pharynx (rcT1/T2/T3 selected rcT4a N0/N+) who will have to undergo STL and who will meet the following criteria. Patients undergoing extensive laryngectomies or with disease with even partial involvement of the pharyngeal mucosa (pyriform sinus, posterior wall of the pharynx) will not be included.
Who may be able to join
- Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:
- pre (ChT-)RT staging: cT1/T2/T3 N0/N+;
- pre STL staging: rcT1/cT2/ Selected cT3 cT4a (extension to thyroid cartilage and/or prelaryngeal tissues) N0/N+ (clinically and radiologically).
- Indication for STL surgery (no pharyngeal mucosal resection);
- Functional total laryngectomies after radical (chemo-)radiotherapy treatment;
- Age > 18 years;
- Signature of informed consent and ability to complete in-office questionnaires.
Who cannot join
- STL extended to the pharynx and/or total pharyngeal laryngectomies;
- Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension;
- Previous open organ preservation surgery (OPHL).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, Rome, 00144
Pellini Raul, Doctor, 06-52664484, raul.pellini@ifo.it
About this study
Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)
Read the detailed description
Patients, once eligibility has been verified, will then be randomized (1:1) to one of the following groups: Gruop 1: STL primary suture. Group 2: STL primary suture + onlay flap Patients in both groups will then undergo surgery STL with primary suture; in those of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. 4 months after surgery, questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire) and swallowing rehabilitation (SOAL questionnaire). Demographic and preoperative data will be collected, data relating to pre-(chemo-)radiotherapy and pre-STL clinical staging, as well as the interval in days between the end of (chemo-)radiotherapy and surgery, perioperative data, type of eventual unilateral or bilateral laterocervical lymph node emptying, the type of pharyngotomy suture, the type of flap possibly used, the packaging of the tracheoesophageal fistula for positioning the voice prosthesis, the definitive histological examination.
The patient must undergo a radiological examination for loco-regional and distant staging before the STL (CT or MRI) and a biopsy demonstrating the recurrence/persistence of the disease.
- Conditions
- Larynx Carcinoma
- Being tested
- Primary suture
- Keywords
- pharyngocutaneous fistula
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary sutureProcedure or surgery
The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)
| Study group | Role | What they receive |
|---|---|---|
| Salvage total laryngectomy STL primary suture | Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing.The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)31. It would be preferable for all centers to use a homogeneous pharyngeal suture technique, such as the T-shaped with Connell suture. Receives: Procedure: Primary suture | |
| Salvage total laryngectomy STL primary suture + onlay flap | Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing, but in the patients of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. Reconstruction with the onlay technique can be performed using a pedicled pectoralis major myofascial flap or anterolateral thigh myofascial free flap at the surgeon's discretion (pharyngeal suture unchanged). The flap will be positioned with an onlay technique to reinforce the pharyngeal suture and in turn sutured to the prevertebral fascia or residual surrounding tissues. Receives: Procedure: Primary suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaires for evaluation of the quality of life
Questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire).
Measured: 30 months
Secondary outcomes (3)
Identification of risk factors
Identification of risk factors related to the formation of pharyngocutaneous fistulas after salvage total laryngectomy
Measured: 4 months
Evaluation of swallowing function
Evaluation of swallowing function assessed using the SOAL questionnaire
Measured: 4 months
Evaluation of vocal rehabilitation
Evaluation of vocal rehabilitation using the SECEL questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start21 Mar 2023
- Primary completion21 Mar 2025
- Study completion21 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raul Pellini, Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287034
- Sponsor's protocol ID
- RS1833/23
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)
- ClinicalTrials.gov ID
- NCT06287034
- Acronym / sponsor ID
- RS1833/23
- Conditions
- Larynx Carcinoma
- Keywords
- pharyngocutaneous fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Sep 2027 (estimated)
- First posted
- 29 Feb 2024 (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.
Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)
Detailed description
Patients, once eligibility has been verified, will then be randomized (1:1) to one of the following groups: Gruop 1: STL primary suture. Group 2: STL primary suture + onlay flap Patients in both groups will then undergo surgery STL with primary suture; in those of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. 4 months after surgery, questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire) and swallowing rehabilitation (SOAL questionnaire). Demographic and preoperative data will be collected, data relating to pre-(chemo-)radiotherapy and pre-STL clinical staging, as well as the interval in days between the end of (chemo-)radiotherapy and surgery, perioperative data, type of eventual unilateral or bilateral laterocervical lymph node emptying, the type of pharyngotomy suture, the type of flap possibly used, the packaging of the tracheoesophageal fistula for positioning the voice prosthesis, the definitive histological examination.
The patient must undergo a radiological examination for loco-regional and distant staging before the STL (CT or MRI) and a biopsy demonstrating the recurrence/persistence of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvage total laryngectomy STL primary suture | – | Procedure: Primary suturePatients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing.The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)31. It would be preferable for all centers to use a homogeneous pharyngeal suture technique, such as the T-shaped with Connell suture. |
| Salvage total laryngectomy STL primary suture + onlay flap | – | Procedure: Primary suturePatients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing, but in the patients of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. Reconstruction with the onlay technique can be performed using a pedicled pectoralis major myofascial flap or anterolateral thigh myofascial free flap at the surgeon's discretion (pharyngeal suture unchanged). The flap will be positioned with an onlay technique to reinforce the pharyngeal suture and in turn sutured to the prevertebral fascia or residual surrounding tissues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from recurrence/persistence of laryngeal SCC following exclusive RT treatment or concomitant RT/ChT without extension to the pharynx (rcT1/T2/T3 selected rcT4a N0/N+) who will have to undergo STL and who will meet the following criteria. Patients undergoing extensive laryngectomies or with disease with even partial involvement of the pharyngeal mucosa (pyriform sinus, posterior wall of the pharynx) will not be included.
Key inclusion criteria (7 listed)
- Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:
- Indication for STL surgery (no pharyngeal mucosal resection);
- Functional total laryngectomies after radical (chemo-)radiotherapy treatment;
- Age > 18 years;
- Signature of informed consent and ability to complete in-office questionnaires.
Key exclusion criteria (3 listed)
- STL extended to the pharynx and/or total pharyngeal laryngectomies;
- Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension;
- Previous open organ preservation surgery (OPHL).
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 |
|---|---|---|
| Primary sutureThe primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches) | Procedure or surgery | Salvage total laryngectomy STL primary suture, Salvage total laryngectomy STL primary suture + onlay flap |
Primary outcome
questionnaires for evaluation of the quality of life
Time frame: 30 months
Questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire).
3 secondary outcomes
Identification of risk factors
Time frame: 4 months
Evaluation of swallowing function
Time frame: 4 months
Evaluation of vocal rehabilitation
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Related trials for Larynx Carcinoma
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
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
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
Raul Pellini, Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institute
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 Larynx Carcinoma, run by Regina Elena Cancer Institute 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 7 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raul Pellini, Doctor (06-52664484 ext. +39, raul.pellini@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaires for evaluation of the quality of life (time frame: 30 months). 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 5 Jun 2026.