Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06088381
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Experimental Observation — OTHER
    Patients on the experimental arm will be under observation only.
  • Observation per Standard of Care — OTHER
    The low-risk group of patients will be observed per standard of care.
  • Adjuvant Treatment per Standard of Care — RADIATION
    The high-risk group of patients will receive adjuvant treatment per standard of care (Radiation with or without chemotherapy)
  • Circulating Tumor DNA test (ctDNA test) — DIAGNOSTIC_TEST
    Blood test for diagnostic and surveillance purposes measuring expression of Cell free HPV tumor DNA (ctDNA) in the blood. Patients will undergo ctDNA within 90 days pre-transoral robotic surgery(TORS), 2-14 days post TORS, then every 3 months (except for at 21 months) for 2 year post completion of initial therapy or salvage therapy.

Study Details

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.

Key Dates

Start date
Mar 7, 2024
Status verified
Nov 2025
Primary completion
Dec 18, 2028
Completion
Dec 18, 2030

Study Design

Enrollment
61 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intermediate Risk Experimental Observation
    Requires the following criteria: 1. Pathological T1-3 N1-2 with negative surgical margins 2. Absent or microscopic extracapsular extension(ECE) (≤1mm) 3. ctDNA positive pre-operatively and negative post-operatively This group will undergo observation on the experimental arm of the study. They will be monitored for toxicity, Quality of Life (QoL) and outcomes evaluation. Suspected locoregional recurrence (LRR) based on physical examination, imaging or increasing ctDNA will undergo completion of workup at the discretion of the University of Maryland Head and Neck tumor board. LRR will be offered salvage treatment based on recommendations from multi-disciplinary discussion. Salvage therapy could include surgical resection (with or without adjuvant treatment), and definitive RT (with or without chemotherapy).

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 2 year post last treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Maryland Proton Treatment CenterBaltimoreMaryland21201
Kelly Kitzmiller
[email protected]
410-369-5246
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201
Kelly Kitzmiller, BS
[email protected]
410-369-5246
Upper Chesapeake HealthBel AirMaryland21014
Lalicia Roman
[email protected]
443-643-1877
Central Maryland Radiation OncologyColumbiaMaryland21044
Kelly Kitzmiller
[email protected]
410-369-5246
Baltimore Washington Medical CenterGlen BurnieMaryland21061
Pilar Strycula
[email protected]
Pilar

Find similar trials in Baltimore, MD

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Maryland Proton Treatment Center· Baltimore, MDUniversity of Maryland Greenebaum Cancer Center· Baltimore, MDUpper Chesapeake Health· Bel Air, MDCentral Maryland Radiation Oncology· Columbia, MDBaltimore Washington Medical Center· Glen Burnie, MD

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