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:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT03164460
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
* Not eligible for surgery for recurrence or poor surgical candidate
* Gross disease apparent on imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\])
* 1-3 sites of recurrence (\< 60 cc per site, total volume \< 100 cc)
* Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
* Negative pregnancy test for women of child bearing potential
Exclusion Criteria:
* Patients who are pregnant or breast feeding
* Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
* a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
* b) No myocardial infarction within 3 months of registration
* Widely metastatic disease (oligometastatic disease acceptable)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03164460
Study Brief:
Protocol Section:
NCT03164460