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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT02388932
Eligibility Criteria:
Inclusion Criteria:
* The participant must have squamous cell carcinoma proven by histologic diagnosis; for cancers of the oropharynx, p16 staining by immunohistochemistry must be negative; for cancers of the larynx, hypopharynx, oral cavity, nasopharynx, paranasal sinuses, p16 staining is not required
* The participant must have clinical stage T1-4, N0-3, M0-1, stage II-IVC carcinoma as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging manual; participants with T1N0M0 will be ineligible; participants with metastatic disease with a limited metastatic burden are eligible if obtaining local control is determined by their treating oncologist to be an important therapeutic goal
* The participant must have imaging documenting a primary tumor, or involved lymph node, ≥ 2.5 cm in greatest dimension
* PET/CT is required for all participants, unless contraindicated; this may be acquired prior to study entry or after enrollment prior to SBRT planning
* The participant must have a history and physical documented within four weeks of registration and be deemed by a medical oncologist to be ineligible for standard continuous course chemoradiotherapy with cisplatin
* Karnofsky performance status (PS) ≥ 40
* Female participants cannot be of childbearing age, or if they are, must have a negative pregnancy test prior to enrollment and be willing to use contraceptives during treatment and continue for 6 additional months
* Participants must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Participants with T1N0M0 stage I disease
* Participants who are receiving any other investigational agents
* Participants with non-squamous cell histology
* Participants with life expectancy \< 6 months
* Participants who cannot lie flat for 20 minutes
* Participants with prior history of head and neck radiotherapy (\> 40 Gy) with significant areas of anticipated overlap
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02388932
Study Brief:
Protocol Section:
NCT02388932