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

Primary Purpose

Oropharyngeal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiotherapy fractionation
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Cancer focused on measuring HPV, Radiotherapy Fractionation, Proliferation Saturation Index, Larynx, Pharynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • H Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard Fractionation

Hyperfractionation

Arm Description

Standard Radiotherapy Fractionation

Hyperfractionation

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2018
Last Updated
February 2, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03656133
Brief Title
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
Official Title
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy Fractionation for Patients With HPV+ Oropharyngeal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer
Keywords
HPV, Radiotherapy Fractionation, Proliferation Saturation Index, Larynx, Pharynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Fractionation
Arm Type
Active Comparator
Arm Description
Standard Radiotherapy Fractionation
Arm Title
Hyperfractionation
Arm Type
Active Comparator
Arm Description
Hyperfractionation
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy fractionation
Intervention Description
Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
Primary Outcome Measure Information:
Title
Percentage of response at week 4 of treatment
Description
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%.
Time Frame
At 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Rate of complete response at 2-3 months
Description
Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy
Time Frame
2-3 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy Caudell, MD, PhD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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

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