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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT07227792
Eligibility Criteria:
Inclusion Criteria:
1. Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).
2. Patients with metastatic disease will be included if the following criteria are met:
* Definitive RT dose is planned for the primary site
* The number of metastatic lesions is ≤5
* All metastatic lesions are confined to a single organ (e.g., lung)
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
4. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening.
* Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
* Female subjects of childbearing potential must utilize an appropriate method of birth control such as hormonal methods (oral, injectable, implant, skin patch, vaginal ring), intrauterine devices, barrier methods (consistent use of male/female condoms, diaphragms, cervical caps), surgical methods (vasectomy, tubal ligation), or true abstinence.
5. Must be able to comfortably protrude tongue in the treatment position for at least 1 minute.
6. Must have the ability to understand and the willingness to sign a written informed consent document.
7. Must be willing to comply with all study procedures.
8. Must be able to complete patient-reported outcome (PRO) questionnaires in English.
Exclusion Criteria:
1. Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
2. Posterior pharyngeal wall primary tumor
3. Widely metastatic disease
4. Surgical resection of the primary tumor
5. Induction chemotherapy or immunotherapy prior to planned radiotherapy
6. Prior head and neck radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07227792
Study Brief:
Protocol Section:
NCT07227792