About this trial
Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.
For this reason this study is looking at a different regimen of reducing the intensity of the treatment.
The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
P16-positive based on local site immunohistochemical tissue staining
Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
Disqualifiers
Metastatic disease
Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
Synchronous double primaries
Prior radiotherapy for lymphoma or other malignancy
Trial design
Single group
Treatments tested in this trial
Modified dose and fields intensity modulated radiotherapy
RadiationInstead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach.
Treatment groups
Trial outcomes
Primary outcomes
Two-year progression free survival
Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx.
Secondary outcomes
Benefit and Tolerance of Treatment
Frailty index G8 score 14 as major determinant of benefit and tolerance to treatment through: Per prior study score \<14 (1-17) is an indicator of frailty. The frailty as a factor in completing therapy (yes or no) and number of days break from therapy will be used as a variable. G20 frailty index (G-20 is the actual name and not abbreviation) is as follows: A Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties? B Weight loss during the last 3 months C Mobility D Neuropsychological problems E Body Mass Index (BMI (weight in kg) / (height in m²) F Takes more than 3 medications per day G In comparison with other people of the same age, how does the patient consider his/her health status? H Age
Acute Toxicity
Acute toxicity (Grade 3 or higher)
Late toxicity
Late toxicity (Grade 3 or higher)
Failure pattern
Pattern failure (local in field, local marginal miss, local regional failure, distant failure, combination of the above). As some of the patient may have recurrence in the radiation fields, this will be termed local recurrence. Recurrence outside the radiation fields but in the head and neck area will be quantified as regional failure. Failure outside the head and neck area will be classified as distant failure. This outcome will be quantified as global number of failure out of the 20 patients and their distribution will be quantified in a diagram as explain above.
Sponsors and contacts
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Omar Mahmoud
Lead sponsor
Baptist MD Anderson Cancer Center, Florida
Sponsor institution