HPV (Human Papillomavirus)-Associated Clinical Trial
Official title:
A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx
| NCT number | NCT01891695 |
| Other study ID # | 16766 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2013 |
| Est. completion date | December 2016 |
| Verified date | September 2022 |
| Source | University of Virginia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering. The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | December 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - patient must be clinically referred for radiation for stage I-IVb OPSCCA - tumor must be HPV-associated p16+ - patient must be able to lie flat and tolerate immobilization systems Exclusion Criteria: - patients may not be receiving any investigational agents - prior radiation to head and neck - any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years - any major medical, psychiatric, or neurologic illness - pregnant or breastfeeding women |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Virginia Health System | Charlottesville | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Paul W. Read, MD |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | N0 Nodal Control Rate | Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA) | Up to 3 years post treatment | |
| Secondary | Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck | Evaluated safety and tolerability of treatment of p16+ OPSCCA by overall incidence of adverse events, incidence of acute and late toxicities and subject-rated quality of life assessments. | Up to 3 years post treatment | |
| Secondary | Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck | Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial | Up to 3 years post treatment | |
| Secondary | Dose Volume Histograms (DVH) | Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck | Up to 3 years post treatment |