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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy Fractionation for Patients With HPV+ Oropharyngeal Cancers

Conditions
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Oropharyngeal Cancer

Intervention / Treatment
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* Radiation: Radiotherapy fractionation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy Fractionation<br>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) | Radiation: Radiotherapy fractionation<br>* Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Response at Week 4 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. | At 4 weeks of treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Radiotherapy Fractionation, Proliferation Saturation Index, Larynx, Pharynx