Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT02516969
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02516969
Study Brief:
Protocol Section:
NCT02516969