HPV (Human Papillomavirus)-Associated, Oropharyngeal Squamous Cell Carcinoma (OPSCCA)
Conditions
Brief summary
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.
Detailed description
A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.
Interventions
RADIATION39.6 Gy radiation
Sponsors
Paul W. Read, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| N0 Nodal Control Rate | Up to 3 years post treatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck | Up to 3 years post treatment | 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. |
| Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck | Up to 3 years post treatment | Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial |
| Dose Volume Histograms (DVH) | Up to 3 years post treatment | Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reduced Intensity Radiation 39.6 Gy radiation to clinically uninvolved cervical lymphatics
39.6 Gy radiation | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Reduced Intensity Radiation |
|---|---|
| Age, Continuous | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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)
Time frame: Up to 3 years post treatment
Population: Study was stopped prematurely after 1 subject was enrolled. No analysis was performed.
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.
Time frame: Up to 3 years post treatment
Population: Study was terminated after one subject enrolled. No analysis performed.
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
Time frame: Up to 3 years post treatment
Population: Study was halted early. Only one subject was enrolled. No analysis performed.
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
Time frame: Up to 3 years post treatment
Population: No analysis performed. Study was terminated after one subject was enrolled.