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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT02031250
Eligibility Criteria:
Inclusion Criteria:
* Patients must have pathologically-confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage III/IV, referred for definitive chemo-RT, and meet one of the following six criteria:
1. Primary tumor (T4) with or without metastatic lymph nodes. Tumor or nodes are: unresectable, resection is considered by the treating surgeon or patient to result in unacceptable functional or oncological results, patient refuses surgery, or surgery is not possible due to comorbidities.
2. HPV(-) (Human Papillomavirus) or p16(-) locally/regionally advanced (T3-4 or N2-3) oropharyngeal cancer.
3. HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
4. T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (\>40 cc\*), unresectable, or patient declines surgery.
5. Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery.
6. Locally/regionally advanced (stage T3-4 and/or N3) nasopharyngeal cancer which is EBV (-) (Epstein-Barr Virus).
* KPS (Karnofsky Performance Status: A measure of general well being and activities of daily living; scores range from 0 to 100 where 100 represents perfect health) \>70 (see Appendix A) within two weeks of enrollment.
* Pre-treatment laboratory criteria within four weeks of enrollment:
* WBC (White Blood Cell) \> 3500/ul, granulocyte \> 1500/ul.
* Platelet count \> 100,000/ul.
* Total Bilirubin \< 1.5 X ULN.
* AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) \< 2.5 X ULN.
* Estimated Creatinine clearance \>30cc/min.
* Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist.
* Patients are adults (Age ≥18).
* All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
* EBV (+) Nasopharyngeal Carcinoma in the protocol treated tumor.
* Prior head and neck radiation.
* Documented evidence of distant metastases.
* Patients with active infection.
* Pregnant women.
* Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02031250
Study Brief:
Protocol Section:
NCT02031250