Surgery With or Without Adjuvant Stereotactic Body Radiotherapy
Completed · Not applicable
Conditions studied: Head and Neck Cancer
In brief
Comparison of patients with operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT.
Key facts
- Study ID
- NCT02516969
- Run by
- David A. Clump, MD, PhD
- People needed
- 7
- Starts
- 2015-08-01
- Expected to finish
- 2021-08-06
- Last updated by the study team
- 2022-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- UPMC Shadyside Radiation Oncology — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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