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NCT Number: NCT03656133

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

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.

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Key information

Conditions

Oropharyngeal Cancer Head and Neck Neoplasms Laryngeal Diseases Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy fractionation

Radiation

Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)

Primary outcomes

  1. Percentage of Response at Week 4 of Treatment

    Time frame: 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 outcomes

  1. Rate of Complete Response at 2-3 Months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Sep 4, 2018
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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