- Patients must have pathologicallyconfirmed, previously untreated, nonmetastatic
locally/regionally advanced squamous cell carcinoma of the head and neck, stage
III/IV, referred for definitive chemoRT, and meet one of the following six criteria:
1. Primary tumor and/or metastatic lymph 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 (T34 or
N23) oropharyngeal cancer.
3. HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer
with >10 pack year smoking history.
4. Locally advanced, bulky (>6 cc*) T3 or T4 laryngeal or hypopharyngeal cancer in
patients who decline 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 T34 and/or N3) nasopharyngeal cancer which
is EBV () (EpsteinBarr 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.
- Pretreatment 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.
- EBV (+) Nasopharyngeal Carcinoma.
- 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.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both