Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx "ENID"
University of Missouri-Columbia
Summary
This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.
Description
This is a trial of definitive chemotherapy and radiation therapy in human papilloma virus positive oropharyngeal cancers, in a population whose cancer is thought to be highly radio-sensitive. This is a population whose outcomes are already known to be very good with high rates of local and distant control of the disease. With the long term disease control and survival of patients with this disease, long term treatment toxicity and resulting reduction in quality of life poses new problems. This has lead to several studies to examine the role of radiation dose de-escalation through various strat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up. * Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment. * Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid…
Interventions
- DrugCisplatin injection
Standard dose cisplatin given concurrently with radiation therapy
Location
- University of MissouriColumbia, Missouri