Clinical Trials

IRB Study Number CC00192

Status Recruiting

Location Cleveland Clinic Main Campus

Institute Taussig Cancer Institute

Description

1. Primary Objectives

   • To establish a registry for patients with head and neck cancer being treated definitively with both operative and non-operative based treatments
   • To quantify treatment related tumor outcomes (e.g. local control, regional control, distant metastasis free survival, freedom from
     recurrence, overall survival, and cause specific survival) and normal tissue outcomes (e.g. acute and late toxicities, patient
     reported quality of life), in this patient cohort

2. Secondary Objectives

   • To explore how patient related characteristics (e.g age, race, performance status, tobacco exposure) are associated with tumor and normal
     tissue related outcomes
   • To explore how tumor related factors (e.g. T stage, N stage, human papilloma virus status, histology, grade) are correlated with distinct
     tumor and normal tissue related outcomes
   • To explore how treatment related variables (e.g. use and type of chemotherapy, radiation dose, fractionation, modality, type of surgery,
     use of robotic surgery) affect tumor response and normal tissue toxicity
   • To utilize these findings to help develop evidence based risk stratification schemes to tailor clinical decision making and inform
     clinical trial design

Inclusion Criteria

• This registry will include patients who present with locoregionally confined (M₀) head and neck cancer and are treated definitively with
  surgery, radiotherapy, chemotherapy, or combined modalities at the Cleveland Clinic. Cancers of the pharynx, larynx, oral cavity,
  nasal cavity, thyroid, salivary glands, paranasal sinuses, skull base and regional skin will be included
• Eligibility will include all patients who are seen in consultation at the Cleveland Clinic and who have agreed to undergo definitive
  treatment at this institution

Exclusion Criteria

none