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

Oropharyngeal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03656133
• Other study ID #: MCC-19579
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: July 30, 2024
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Radiation:
• Radiotherapy fractionation
Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (= 6 hours apart)

Locations

Country	Name	City	State
United States	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2-3 months post treatment