A Phase II Study of Transoral Surgical Removal of HPV-Positive Locally Advanced Oropharynx Cancer Followed by Risk-Stratified Therapy

Protocol
14-035
Full Title
Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer (ECOG 3311)
Phase
II
Disease Status
Relapsed/Refractory
Purpose

Infection with the human papillomavirus (HPV) is a cause of oropharynx cancer. Treatment for cancer of the oropharynx (the region where the mouth meets the throat) may involve surgery, chemotherapy, and/or radiation therapy. This treatment can have side effects that impair speech, swallowing, and patients’ overall quality of life. Doctors are therefore looking for ways to determine just how much therapy each patient needs.

In this study, patients with HPV-positive oropharynx cancer will have their tumors surgically removed in an operation that is performed through the mouth (“transorally”). Their tumors will then be examined under a microscope. Based on the results of this examination, researchers will assign (stratify) them into one of four treatment groups:

  • No additional treatment needed
  • Low-dose radiation therapy, delivered in 25 treatments
  • Standard-dose radiation therapy, delivered in 30 treatments
  • Chemotherapy with weekly cisplatin and standard-dose radiation (33 treatments)

Researchers will compare the four groups to determine if this approach is an effective way of treating locally advanced HPV-positive oropharynx cancer.

Eligibility

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

  • Patients must be newly diagnosed with stage III, IVa, or IVb squamous cell or undifferentiated carcinoma of the oropharynx.
  • Patients may not have previously received treatment for their cancer, nor any prior radiation therapy above the collarbone.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Luc Morris at 212-639-3049.

Disease(s)
Head & Neck Cancer
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