Last updated on July 2019

Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Malignant Neoplasms of Lip Oral Cavity and Pharynx | Oropharyngeal Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging.
  2. Age >/= 18 years
  3. Clinical stage T1-2, N0-1, or small volume N2b (AJCC, 7th ed.), with no distant metastases, based on routine staging workup.
  4. Positive for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (ISH)
  5. Lifetime pack-year history of <10 years, currently non-smoking for at least 5 years.
  6. No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
  7. No lymph nodes larger than 3 cm in the greatest dimension
  8. No retropharyngeal nor level IV (or lower) lymphadenopathy (i.e. nodes in level I-III only)
  9. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
  10. Dispositioned to single modality photon radiotherapy (i.e. no chemotherapy or previous therapeutic intent surgery).
  11. For females of child-bearing age, a negative pregnancy test

Exclusion Criteria:

  1. Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
  2. Pregnant or breast-feeding females
  3. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: *Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
  4. Myocardial infarction within 3 months of registration
  5. Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices.
  6. History of claustrophobia
  7. Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m^2

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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