Evaluating flap use in laryngectomy after failed cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized study aims to assess the risk of pharyngocutaneous fistula (PCF) in patients undergoing salvage total laryngectomy (STL) for laryngeal carcinoma after failure of (chemo-)radiotherapy. Participants will be randomly assigned to two groups: one receiving STL with primary suture and the other receiving STL with an additional onlay flap technique. The study will collect demographic, clinical, and perioperative data, and patients will complete questionnaires four months post-surgery to evaluate quality of life related to voice and swallowing rehabilitation. The goal is to determine if the flap technique reduces the risk of PCF compared to primary suture alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:

  1. pre (ChT-)RT staging: cT1/T2/T3 N0/N+;
  2. 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 Criteria:

* 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).

Where it's running

• "Regina Elena" National Cancer Institute
  Rome, Rome, Italy Recruiting

Study contacts

• Principal investigator: Raul Pellini, Doctor — IRCCS "Regina Elena" National Cancer Institute
• Study coordinator: Raul Pellini, Doctor
• Email: raul.pellini@ifo.it
• Phone: 06-52664484

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.