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Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03656133•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

September 26, 2018

Primary Completion Date

March 14, 2022

Completion Date

March 26, 2024

Last Updated

February 20, 2026

Enrollment

ACTUAL participants

Conditions

Oropharyngeal Cancer

Interventions

Radiotherapy fractionation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma

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