Salvage Surgery in Recurrent Hypopharyngeal Carcinoma: an Observational Single-institutional Study From 1998
Salvage Surgery in Recurrent Hypopharyngeal Carcinoma: Anobservational Single-institutional Study From 1998
Study Overview
Status
Conditions
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Lombardy
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Pavia, Lombardy, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- recurrence of hypopharynx/hypopharyngolarynx cancer after the first hypopharynx/hypopharyngolarynx tumor;
- treatment with salvage surgery and reconstruction using free or pedicled flaps.
Exclusion Criteria:
- recurrence of cancer in a location other than the hypopharynx/hypopharyngolarynx or with the first tumor in a location other than the hypopharynx/hypopharyngolarynx;
- treatment with salvage surgery without flap reconstruction or with salvage treatment not involving flap reconstruction
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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the difference in proportions of non necrotic complications in the two groups of patients.
Time Frame: up to 24 months
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up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the difference in proportions of necrotic complications in the two groups of patients.
Time Frame: up to 24 months
|
up to 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Salvage_reconstruction
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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