N/A
N=7
Surgery With or Without Adjuvant Stereotactic Body Radiotherapy
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02516969 ↗Enrolled (actual)
7
Serious AEs
28.6%
Results posted
Jan 2022
Primary outcome: Primary: 1-year Local Control — NA; NA months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Body Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David A. Clump, MD, PhD
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1-year Local Control |
NA; NA | — |
| SECONDARY Number of Participants With Acute Toxicities of Adjuvant SBRT |
1; 0; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants With Late Toxicities of Adjuvant SBRT |
1; 0; 2; 0; 2; 0 | — |
| SECONDARY Progression-free Survival (PFS) Locoregional |
NA; NA | — |
| SECONDARY Progression-free Survival (DPFS) Distant |
NA; NA | — |
| SECONDARY Overall Progression Free Survival (PFS) |
NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Quality of Life (UW-QoL-R) |
100.00; 75.00; 100.00; 75.00; 75.00; NA | — |
Summary
Comparison of patients with operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02516969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.