Pilot Trial of Adaptive Radiotherapy Boost for HNSCC
The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.
Conditions:
🦠 Squamous Cell Carcinoma 🦠 Head and Neck Cancer
🗓️ Study Start (Actual) 18 December 2023
🗓️ Primary Completion (Estimated) January 2027
✅ Study Completion (Estimated) January 2027
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Tampa, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Provision of signed and dated informed consent form
    • * Stated willingness to comply with all study procedures and availability for the duration of the study
    • * ECOG performance status of 0, 1
    • * Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck.
    • * Patients with measurable disease, either at primary site or neck per RECIST 1.1.
    • * For patients planned to receive chemotherapy, adequate hematologic, hepatic and renal function as outlined in protocol.
    • * International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history.
    • * Negative serum pregnancy test within before starting study treatment in woman with childbearing potential.

    Exclusion Criteria:

    • * Pregnancy or lactation
    • * Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer.
    • * Patients who had undergone definitive surgery for the index cancer.
    • * Patients with distant metastatic disease
    • * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 November 2023
  • First Submitted that Met QC Criteria 13 November 2023
  • First Posted 18 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 March 2024
  • Last Update Posted 22 March 2024
  • Last Verified March 2024