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

NCT03656133 | Completed Results

• 1 other identifier: MCC-19579
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Cancer

Keywords

HPV; Radiotherapy Fractionation; Proliferation Saturation Index; Larynx; Pharynx

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Complete Response at 2-3 Months

  2-3 months post treatment

Study Arms (1)

Radiotherapy Fractionation

EXPERIMENTAL

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

Interventions

Radiotherapy fractionation RADIATION

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

Radiotherapy Fractionation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Laryngeal Diseases

Interventions

Chemical Fractionation

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Jimmy Caudell, MD, PhD
• Organization: Moffitt Cancer Center

jimmy.caudell@moffitt.org

813-745-8226

Study Officials

• Jimmy Caudell, MD, PhD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 4, 2018
• Study Start: September 26, 2018
• Primary Completion: March 14, 2022
• Study Completion: March 26, 2024
• Last Updated: February 20, 2026
• Results First Posted: December 11, 2023

Record last verified: 2026-02

Locations

US (1)