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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02655068
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically confirmed carcinoma arising in the head and neck. Histologies may include squamous cell carcinoma, poorly differentiated carcinoma, carcinoma NOS, basaloid carcinoma, or salivary gland carcinoma (including mucoepidermoid carcinoma, salivary duct carcinoma, adenocarcinoma, and adenoid cystic carcinoma).
2\. Primary site of origin must be one of the following: a) the oral cavity, pharynx, or larynx; b) major or minor salivary gland; c) skin; d) unknown primary site is acceptable in patients with squamous cell carcinoma metastatic to cervical lymph nodes.
3\. Stage III-IVb based upon AJCC 7th edition staging criteria. 4. Serum creatinine ≤ 1.5 mg/dL (most recent within the last three months) 5. The treating multidisciplinary team agrees that the patient has no evidence of disease (NED) after definitive therapy.
1. Patients who have undergone primary surgery with R0 or R1 resection are eligible to enter the protocol for 6 weeks after the date of definitive surgery. Note: Patients treated with primary surgery will undergo first study surveillance 3 months (+/- 30 days) after the date of definitive surgery.
2. Patients who have undergone primary radiotherapy (including chemoradiotherapy) must have completed first response assessment 6-14 weeks after completion of radiotherapy. To be eligible, patients must be determined by the multidisciplinary team to without clear evidence of residual disease, without need of surgical consolidation, and appropriate to enter surveillance. Such patients are eligible to enter the surveillance protocol for 6 weeks after the date of first response assessment. Patients requiring surgical consolidation of the primary site and/or neck are eligible following the consolidative surgery, provided benign findings or negative margins were attained. Such patients are eligible to enter the surveillance protocol for 6 weeks after the date of consolidative surgery.
Note: Patients treated with primary radiotherapy will undergo first study surveillance 6 months (+/-30 days) after completing radiotherapy.
6\. In the case of oropharyngeal primary squamous cell carcinomas, HPV status must be classified per standard of care. HPV(+) disease will be those cases which demonstrate diffuse nuclear and cytoplasmic staining in ≥ 70% tumor cells by p16 immunohistochemistry (IHC).
7\. Age ≥ 18 years 8. Able to provide written, informed consent 9. ECOG Performance Status 0-2
Exclusion Criteria:
* Severe allergy to iodinated contrast, despite appropriate premedications 2. Presence of gross residual disease after surgical resection 3. Serum creatinine \> 1.5 mg/dL 4. Who Type II or III non-keratinizing squamous cell carcinoma of the nasopharynx
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02655068
Study Brief:
Protocol Section:
NCT02655068