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Clinical Trials: Cancer - Head and Neck, Including Mouth
IRB No. 14-162-2 (Dr. Patricia Diaz, PI): The prevalence of culturable and non-culturable fungi among patients with cancer undergoing chemotherapy treatment alone or in combination with head neck radiotherapy and non-cancer controls
To conduct a pilot comparison of the prevalence and abundance of culturable and non-culturable fungi among individuals diagnosed with cancer (during the course of chemotherapy alone or combined with head and neck radiation therapy) and non-cancer subjects.
IRB No. 14-179-1 (Dr. Rajesh Lalla, PI): Oral Microbiome in Head and Neck Cancer Patients
This research study is about the community of germs that live in the mouth (the oral microbiome) and its relationship to oral complications of radiation therapy such as dryness, mouth sores, tooth loss, cavities, gum disease or poor healing of bone. The purpose of this study is to look at changes in the oral microbiome from before radiation therapy until 18 months after radiation therapy to see if certain characteristics of the oral microbiome relate to mouth problems that may occur after radiation therapy. An optional sub-study is about future genetic testing of saliva samples to look for genes that may affect the risk of oral complications of radiation therapy..
IRB No. 16-007-1 (Dr. Upendra Hegde, PI): A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Head and neck cancer describes a range of tumors that arise in the head and neck region, which includes the oral cavity, pharynx, larynx, nasal cavity, paranasal sinuses, thyroid, and salivary glands. The worldwide incidence of head and neck cancer exceeds half a million cases annually, ranking it as the fifth most common cancer worldwide, and accounts for 5% of all malignancies. A large number of patients with head and neck cancer initially present with locally advanced, stage III/IV disease that is initially treated with combinations of chemotherapy, radiation and/or surgery. This initial treatment is generally designated as "definitive" therapy, which typically combines chemoradiation and surgery and can result in disease control rates ranging between 33 and 86% of patients. Patients who progress after initial definitive therapy require subsequent treatment for recurrent (R) disease. Patients who initially present with metastatic (M) disease generally receive the same therapy as those with recurrent disease after definitive treatment. In this trial, subjects with oropharynx cancer will be stratified by HPV status (positive or negative). The favorable prognostic significance of HPV-positive head and neck cancers in the oropharynx has been increasingly established. Preliminary data of single agent pembrolizumab in head and neck cancer patients in KEYNOTE-012 demonstrate efficacy in both HPV-positive and HPV-negative patients. Investigator site assessment of HPV using immunohistochemistry (IHC) staining for the p16 protein will be used for the subjects with oropharyngeal cancer prior to randomization. Study design This is a randomized, active-controlled, multi-site, open-label trial of pembrolizumab, or pembrolizumab plus platinum plus 5-FU chemotherapies versus platinum plus 5-FU plus cetuximab in subjects with advanced head and neck cancer. Study population and sample size Subjects with recurrent or metastatic Head and Neck Squamous Cell Carcinoma. Approximately 750 subjects will be enrolled. Major Study Interventions (1) Pembrolizumab (MK-3475) 200 mg every 3 weeks; or (2) Pembrolizumab (MK-3475) 200 mg every 3 weeks + Platinum + 5- Fluorouracil (5-FU); or (3) Cetuximab 400 mg/m2 initial dose followed by 250 mg/m2 (weekly) + Platinum + 5FU (Platinum is either Cisplatin 100 mg/m2 Q3W or Carboplatin AUC 5 Q3W; 5FU is 1000 mg/m2 continuous from Day 1 to Day 4 Q3W) Main Outcome Measures/Analyses Primary Objectives (1) Objective: To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by central radiologists' review in a subgroup of first line recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects with strongly positive PD-L1 expression, treated with Pembrolizumab monotherapy versus standard treatment cetuximab with chemotherapy. (2) Objective: To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by central radiologists' review in subjects with first line R/M HNSCC treated with pembrolizumab monotherapy or a combination of Pembrolizumab with chemotherapy versus standard treatment cetuximab with chemotherapy.
IRB No. 14-041HO-1 (Dr. Rajesh Lalla, PI): Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)
The ORARAD study is a prospective cohort study to document dental and other oral outcomes in patients who receive radiation therapy as part of treatment for a head and neck cancer. Seven hundred and fifty-six participants will be enrolled nationally over a three year period. Of these, 135 will be enrolled at UCHC. All participants will be seen for the study before starting radiation therapy then at six-month intervals for up to two years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss after radiation therapy. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.