Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-99
SponsorOmar Mahmoud

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

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Omar Mahmoud

Lead sponsor

Baptist MD Anderson Cancer Center, Florida

Sponsor institution