Pittsburgh, Pennsylvania 15232


Purpose:

Comparison of 1-year local control in patients with operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT.


Study summary:

The primary objective of this study is to compare the 1-year local control in patients with operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT. The secondary objectives of this study are to determine the locoregional progression-free survival (PFS) distant PFS, overall PFS (local + regional + distant), and overall survival (OS), to evaluate the acute and late toxicities of adjuvant SBRT in the re-irradiation setting following salvage surgery, to determine prognostic factors that may predict the likelihood of local failure, regional failure, or OS in this cohort to guide future management, to compare the impact of adjuvant SBRT versus a wait-and-see approach on patient reported quality of life (PR-QoL), and to compare surgical versus SBRT-induced immunological serum markers in relation to local control.


Criteria:

Inclusion Criteria: - Pathologically proven recurrent or second-primary head-and-neck cancer receiving prior radiotherapy with or without chemotherapy. - Prior radiotherapy to a dose of ≥50Gy - No evidence of distant metastases - Macroscopic complete salvage surgery with curative intent (surgery was not performed only for biopsy or palliation). Final pathology and imaging must indicate a R0 or R1 resection (no gross disease remaining). - High-risk pathologic features must be present: compromised/positive surgical margins (≤ 2mm) or extra-nodal extension (patient with other high-risk features gross perinueral invasion, bone invasion, angiolyphatic invasion, or a constellation of these factors may be eligible based on case-by-case basis at discretion of principal investigator). - Karnofsky Performance Status ≥60 (ECOG 0-2) - Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team) Exclusion Criteria: - Evidence of distant metastases on any staging or imaging modality - Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study if randomized to SBRT treatment arm) - Any patient with gross residual disease following salvage surgery - Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator.


NCT ID:

NCT02516969


Primary Contact:

Principal Investigator
Dwight E Heron, MD
University of Pittsburgh


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15232
United States

Karen D Holeva, BS
Phone: 412-623-1275
Email: holevakd@upmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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