Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers

Not Applicable

Completed

Brief Summary: This study is to determine whether a mathematical model can be used to choose a radiation delivery method to improve the rate of a rapid response.

Detailed Description: Investigators hypothesize that using individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) may improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).

Recruitment & Eligibility

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥ 18 years
Pathologically (histologically or cytologically) proven diagnosis of p16+ or HPV+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, and may consist of pathology, palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
American Joint Committee on Cancer (AJCC) 8th edition staging T1-3 N0-1 MO
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
CT or MRI performed at least 1 week apart. This can consist of diagnostic imaging and radiation therapy planning imaging.
No evidence of distant metastases
Eastern Cooperative Oncology Group Performance Status 0 to 3

Exclusion Criteria

Age < 18
Positive urine pregnancy test
Evidence of distant metastases
Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that remove all clinically and radiographically evident disease
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Patients with a medical condition or social situation that at the discretion of the PI would preclude them from completion of the trial

Arm && Interventions

Group	Intervention	Description
Radiotherapy Fractionation	Radiotherapy fractionation	Investigators will use an individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) to improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks). Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)

Primary Outcome Measures

Name	Time	Method
Percentage of Response at Week 4 of Treatment	At 4 weeks of treatment	Fractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4.

Secondary Outcome Measures

Name	Time	Method
Rate of Complete Response at 2-3 Months	2-3 months post treatment	Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy