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
Qualifiers
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
Treatments tested in this trial
- Modified dose and fields intensity modulated radiotherapy
Treatment groups
Sponsors and collaborators
Omar Mahmoud
Lead sponsor
Baptist MD Anderson Cancer Center, Florida
Sponsor institution