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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07337161
Eligibility Criteria:
Inclusion criteria
* Age ≥ 18 years
* Patient able to provide informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patient is a candidate for curative intent treatment
* Patient is able to comprehend English adequately to complete patient reported outcome questionnaires
* Biopsy-confirmed cutaneous SCC
* Definitive resection of a primary cutaneous tumor within the head and neck
* Tumor stage T1-T4 (AJCC 8th edition); or tumor stage unknown (T0/Tx) with a positive intraparotid, peri-parotid or cervical node that is assumed to be from a head and neck cutaneous SCC by the treating oncologist
* Nodal stage N1-N3 (AJCC 8th edition)
* At least 1 indication for adjuvant radiation, including:
* T3 or T4 tumor stage
* Lymphovascular invasion (LVI)
* Perineural invasion (PNI)
* Positive or close (≤ 3 mm) margin
* ≥ 1 positive intraparotid, peri-parotid or cervical lymph node
* Multiple local recurrences or multi-focal disease
* Neoadjuvant or adjuvant immunotherapy is allowed
Exclusion criteria
* Definite metastatic disease at diagnosis
* Pregnant or breastfeeding women
* Significant health conditions or contraindications to receiving surgery and radiation
* History of previous head and neck cancer within 5 years, except for localized skin cancers (i.e. no nodal or distant spread)
* Prior head and neck radiation involving the ipsilateral parotid or neck. However, prior radiation to the index skin cancer that has led to the parotid nodal disease being treated on this trial is allowed, as long as there is no overlap, or inconsequential overlap, in the judgement of the treating oncologist.
* Indications for contralateral neck radiation (i.e. contralateral or bilateral lymph nodes)
* Previous invasive malignancy within 5 years, unless controlled with no evidence of disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07337161
Study Brief:
Protocol Section:
NCT07337161