Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma Based on HPV Subtype and Plasma Circulating Free HPV DNA Level and Clearance Rate

University of Florida3 sites in 1 country250 target enrollmentMay 16, 2022

ConditionsOropharyngeal Squamous Cell Carcinoma

InterventionsRadiation therapy Cisplatin

DrugsCisplatin

Overview

Phase: Phase 2
Intervention: Radiation therapy
Conditions: Oropharyngeal Squamous Cell Carcinoma
Sponsor: University of Florida
Enrollment: 250
Locations: 3
Primary Endpoint: Local-Regional Control Rate
Status: Recruiting
Last Updated: 8 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Registry

clinicaltrials.gov

Start Date

May 16, 2022

End Date

June 1, 2032

Last Updated

8 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥ 18 years of age (no upper age limit)
•T0-3, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level
•Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.
•Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is acceptable.
•ECOG Performance Status 0-2
•≤10 pack-years of smoking or no smoking for ≥ 10 years
•Eligible for chemotherapy
•CBC/differential obtained within 12 weeks prior to treatment, with adequate bone marrow function defined as follows:
•Platelets ≥ 100,000 cells/mm3
•Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)

Exclusion Criteria

•Prior radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) OR to the head and neck that, if combined with the protocol therapy, is deemed likely to compromise critical organs at risk in the opinion of the investigator.
•Prior cancer within the last 10 years.
•This exclusion does not apply to the history or presence of any non-oropharynx cancer when the treating physician (or PI) deems that it is resolved or expected to have an indolent growth rate such that evaluation of the efficacy of the study treatment is unlikely to be compromised.
•Prior surgery with curative intent for this OPSCC.
•Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is "gross" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with "gross" defined as visible on an imaging study.
•Inhalation smoking of tobacco within the last 10 years with \> 10 pack-year equivalent history.
•Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.
•Severe, active co-morbidity, defined as follows:
•Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
•Transmural myocardial infarction within the last 6 months

Arms & Interventions

Chemo-radiotherapy

Participants will receive chemo-radiotherapy.

Intervention: Radiation therapy

Chemo-radiotherapy

Participants will receive chemo-radiotherapy.

Intervention: Cisplatin

Outcomes

Primary Outcomes

Local-Regional Control Rate

Time Frame: 2 years

Determine the Local-Regional Control Rate, defined as the absence of recurrence of OPSCC at the primary site or in a neck node that was included in a radiation therapy target volume