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
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
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
NCT ID
NCT03656133
First Posted
August 30, 2018
Last Updated
February 2, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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
Learn more about this trial
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
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