Surgical Repair Methods After Failed Radiotherapy for Throat Cancer
Compares two surgical closure methods after total larynx removal in adults with laryngeal cancer.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Regina Elena National Cancer InstituteRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regina Elena Cancer Institute
- Trial code
- NCT06287034
- Record updated
- 5 June 2026
- Original description
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 full original descriptionShow less
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)
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)
Inclusion: 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.
Exclusion: Previous open organ preservation surgery (OPHL); STL extended to the pharynx and/or total pharyngeal laryngectomies; Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension.