Head and Neck Oncology Research and Clinical Trials

Researchers at the Department of Otolaryngology – Head and Neck Surgery and the Tisch Cancer Center remain true to Mount Sinai’s mission to provide unrivaled patient care, education, and research to the various diverse communities we serve. Many of the studies and trials below are fully or partially funded by institutional collaborators and the generous support of donors who share our vision for advancing care and improving outcomes for head and neck cancer. See below for some of our active trials.

Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SIRS Trial)
HPV (human papillomavirus)-induced oropharyngeal squamous cell carcinoma represents an epidemic of head and neck cancer. Our multi-disciplinary SIRS Trial seeks to lessen the impact of high-dose radiotherapy and chemoradiotherapy on patients with a good prognosis through studying a reduced dose post-surgery radiation treatment. This trial is radical in that it allows us to lower patients’ exposure to radiation after surgery and base our postsurgical treatment on the pathology of each patient's tumor. This approach increases treatment precision and significantly reduces the side effects of radiation while improving patients’ quality of life. The ultimate success of the SIRS Trial is dependent on the collection of tissue and blood samples from patients pre- and post-treatment for translational studies in predictive genomics, biology and biomarkers of risk. We have already generated significant positive data through this project, and these patient samples are now providing a foundation for biologic studies of oropharyngeal squamous cell carcinoma.

Quarterback 2b Trial
This is a multidisciplinary trial for patients with high risk HPV positive oropharynx cancer that studies the efficacy of chemotherapy followed by reduced dose radiation and, where indicated, surgery. In this trial, patients whose disease is too advanced for surgery and which is still localized to the head and neck are treated with chemotherapy followed by a reduced dose of radiation therapy. Preliminary data has been published demonstrating that this approach is effective and significantly reduces the toxicity experienced by patients, thereby improving quality of life. Through extending the trial with philanthropic support, our scientists are able to treat patients with reduced dose therapy and collect the data to support this approach, potentially transforming the current standard of care.

RBD Trial
The Risk-Based De-Escalation Trial (RBD) is a phase 2 trial designed for patients with HPV related oropharynx cancer who have poor risk factors and/or are not eligible for the SIRS or Quarterback 2b trials. Enrolled patients are offered reduced radiation based on prognostic and predictive factors in their tumor or lifestyles. This trial enables patients to benefit from less toxicity but equivalent survival and better quality of life than they would experience with standard of care treatment.

Precision Medicine/Drosophila Avatars for Adenoid Cystic Carcinoma (NCI Grant)
With the support of an NCI grant, our researchers are analyzing the patient and tumor genetics of adenoid cystic carcinoma and creating a small animal model using fruit flies (drosophila). This model will be used to develop therapeutics for patients with this hard to treat salivary gland cancer. The team hopes to leverage the results of this study to develop a predictive model for treatments for patients with adenoid cystic carcinoma.

Curative Induction Immunotherapy for Advanced Head and Neck Cancer
This phase 2 trial, performed in collaboration with the Regeneron, is for patients with locally advanced cancer. The trial combines induction chemotherapy with immunotherapy in order to enhance the curability of these cancers. This novel combination of induction chemotherapy and immunotherapy followed by surgery and or chemoradiotherapy for head and neck cancer is radical and has not been previously explored in depth by pharmaceutical companies or government supported cooperative groups. This trial is supported by Regeneron for both the clinical performance and translational study portions. 

Glioblastoma in HPV Related Oropharynx Cancer
Our research team recently identified two Mount Sinai patients with HPV oropharynx cancer who developed glioblastoma after cure of their initial oropharynx tumor. This was surprising as glioblastoma is a rare tumor, leading our scientists to hypothesize that there might be a relationship between the two cancers. Utilizing a large database at Mount Sinai, our team identified a number of additional patients with oropharynx cancer and are now exploring germline and tumor genetics and larger established databases to determine if there is a biologic relationship in the development of these two malignancies.

Genetic Determinants of Resistance to Induction Chemotherapy in HPV Oropharynx Cancer
In a limited number of patients with HPV positive oropharynx cancer seen by our physicians, disease progressed shortly after completion of primary therapy. These highly aggressive tumors appear to have a different biology compared to the more common HPV related cancers, which are generally more responsive to therapy. To help us better treat these more aggressive cases, our researchers are evaluating the individual tumor genetics in patients with resistant cancers and comparing those to patients whose cancers were highly responsive to treatment. Through this analysis, we hope to identify predictive biomarkers and offer patients both more effective and less toxic treatment.

Quad-Shot Radiation Therapy for Elderly Patients
This study investigates the use of a modified radiation based treatment for head and neck cancer patients with significant comorbidities who cannot tolerate a full course of radiation or chemoradiotherapy. The approach used in this trial changes the timing and manner in which radiation is given in order to improve the overall outcome for patients who otherwise could not tolerate standard treatment. Through this study, our researchers hope to develop a safe and effective therapy for patients who have significant comorbidities. This is a first step in improving treatment and quality of life for these patients.

Oral squamous cell cancer in young people
Exploratory study of the genomic determinants oral squamous cell cancer in young people.  The study will require information on patients treated over the last 10 years under the age of 35 at the time of diagnosis with oral squamous cell carcinoma.  This disease is particularly devastating and has a low cure rate.  Many of these patients are nonsmoker and so the study will attempt to identify genomic determinants either in the germline or within the tumor as well potential demographic factors that impact on cancer development in survival.  The support for this exploratory study will only come from philanthropy.

WTC-Related Pollutants in Thyroid Cancer Tissue
An excess risk of thyroid cancer has been found among World Trade Center (WTC) first responders who have been exposed to the WTC dust. The objective of this study is to investigate the distribution of WTC-related pollutants in tissue of WTC first responders diagnosed with thyroid cancer.

Thyroid Cancer Aggressiveness in Agent Orange Exposed Veterans
The objective of this study is to investigate whether past exposure to 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD), commonly known as Agent Orange, is associated with more aggressive thyroid cancer features, including higher rates of metastasis and cancer recurrence or lower survival, as well as more aggressive genetic changes. Results of this study will be directly applicable to improve current management protocols for thyroid cancer patients exposed to TCDD.