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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT06554158
Eligibility Criteria:
Inclusion Criteria:
* Patients must be ≥ 18 years of age on the day of signing informed consent.
* Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall).
* pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.
* Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.
* neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.
* hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.
* current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history
* start radiation within 8 weeks of resection (6 weeks preferable)
* have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
* Perineural invasion at primary site
* Lymphovascular space invasion at primary site
* Level 4 nodal involvement (even if resected)
* Retropharyngeal nodal involvement (even if resected)
* any intact, unresected disease
* nodal disease pathologically invading adjacent neck musculature
* Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy
* Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance.
* Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06554158
Study Brief:
Protocol Section:
NCT06554158