A Phase II Study of Minimally Invasive Surgery Followed by Radiation and Chemotherapy versus Higher Dose Radiation and Chemotherapy for Patients with HPV-Negative Oropharynx Cancer

Protocol
14-038
Full Title
Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery followed by Risk-Based IMRT and Weekly Cisplatin versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer (RTOG 1221)
Phase
II
Disease Status
Relapsed/Refractory
Purpose

The standard treatment for oropharynx cancer that does not contain the human papillomavirus (HPV) is high-dose radiation therapy plus the chemotherapy drug cisplatin. However, patients who receive this treatment are at risk of long-term speech and swallowing problems. Minimally invasive surgery to remove the cancer through the mouth (“transoral surgery”) and less intensive therapy afterward may be one way to reduce the risk of these side effects.

In this study, patients will be randomly assigned to either investigational therapy or standard therapy, and the groups will be compared. Patients in the investigational therapy group will first have transoral surgery to remove cancerous tissue, followed by either observation, radiation therapy (total dose of 60 Gy), or radiation therapy (60 Gy) plus six weeks of once-weekly cisplatin. Patients in the standard therapy group will receive a total dose of 70 Gy of radiation therapy followed by seven weeks of once-weekly cisplatin.

Eligibility

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

  • Patients must have operable stage III-IV HPV-negative squamous cell carcinoma of the oropharynx.
  • Patients may not have previously received chemotherapy for this oropharynx cancer nor radiation therapy to the head and neck.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ian Ganly at 212-639-6244.

Disease(s)
Head & Neck Cancer
Related Diseases