Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 2:04 AM
Study NCT ID:
NCT07295561
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage Surgery in Recurrent Hypopharyngeal Carcinoma: an Observational Single-institutional Study From 1998
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Study Overview
Official Title:
Salvage Surgery in Recurrent Hypopharyngeal Carcinoma: Anobservational Single-institutional Study From 1998
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study will be to assess the association between the type of a surgical flap and post-operative complication in patients with hypopharyngeal cancer undergoing salvage surgery (SS) and reconstruction with free or pedicled flaps.
Detailed Description:
Squamous cell carcinoma of the hypopharynx (HPSCC) is a rare but aggressive cancer, accounting for only 3-5% of all head and neck cancers. It occurs in the III-IV stage in about 60-85 % of cases, with 5-year overall survival (OS) ranging from 25 to 41%. It tends to spread in local submucosa, with an early involvement of the larynx and the locoregional tissue. Disease recurrence is around 15% to 40%, depending on the casuistry, the type of primary treatment (surgery vs. organ preservation protocols) and personal experience of each center. In recurrence setting, where indicated, salvage surgery (SS) remains the gold standard with the highest survival rates compared to conservative therapy. Generally patients are frail, with poor performance status and countless comorbidities and between 33% to 66% of cases are eligible to surgery with curative intent. In fact, in salvage setting the risk of peri-operative mortality is higher, postoperative complications are more frequent and hospital stay is longer.
Therefore, a careful selection of candidates is imperative and based on the following criteria: age and comorbidities, site of recurrence, stage, time interval since the first treatment and type of previous therapies
Therefore, a careful selection of candidates is imperative and based on the following criteria: age and comorbidities, site of recurrence, stage, time interval since the first treatment and type of previous therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: