NCT06287034Recruiting
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)
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 102 (estimated)
- First submitted
- 12 Jan 2024
- Start date
- 21 Mar 2023
- Primary completion date
- 21 Mar 2025
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT06287034
What you commit to
- Study type: Observational
- Planned participants: 102
- From 21 Mar 2023 to the primary completion date, 21 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous open organ preservation surgery (OPHL).
Other
- STL extended to the pharynx and/or total pharyngeal laryngectomies;
- Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regina Elena National Cancer Institute Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.