A Study Assessing a Major Dose Reduction in Radiation Therapy for HPV-Positive Oropharyngeal Cancer

Full Title

A Prospective Non-inferiority Trial of Major Radiation Dose De-Escalation Concurrent with Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma

Purpose

High-dose radiation therapy plus chemotherapy is a common treatment for oropharyngeal cancer that is positive for the human papillomavirus (HPV). However, this treatment can cause short-term and long-term side effects, especially due to the high doses of radiation. Studies of small groups of patients have suggested that for some patients, lower radiation doses may be just as effective as higher doses for preventing cancer recurrence.

In this study, researchers are assessing the effectiveness of using significantly lower doses of radiation therapy (less than half the usual total dose) in combination with chemotherapy in patients with HPV-positive oropharyngeal cancer. Patients will undergo a special type of positron emission tomography (PET) scanning to assess their tumors’ sensitivity or resistance to radiation. Those whose tumors are sensitive to radiation will receive the lower dose; those whose tumors are resistant will be unable to participate in the remainder of the study and will receive the standard radiation dose.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage II or II HPV-positive oropharyngeal cancer that has been surgically removed but has not yet been treated with radiation therapy or chemotherapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Nancy Lee at 212-639-3341.

Protocol

17-409

Phase

II

Disease Status

Newly Diagnosed

Investigator