Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04477759
Phase
PHASE1
Status
Completed

Conditions

  • Head and Neck Neoplasm

Eligibility Criteria

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

Interventions

  • 50 Gy Radiation Therapy — RADIATION
    Ionizing radiation
  • 55 Gy Radiation Therapy — RADIATION
    Ionizing radiation
  • 60 Gy Radiation Therapy — RADIATION
    Ionizing radiation
  • Concurrent Atezolizumab — DRUG
    Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
  • Adjuvant Atezolizumab — DRUG
    Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.

Study Details

Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve therapeutic outcomes while limiting toxicities. This protocol evaluates a novel framework for radiation delivery with concurrent atezolizumab in patients with advanced HNSCC. Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) modifies radiation dose using MRgRT by escalating radiation dose to residual tumor while deescalating radiation dose to areas of tumor regression.

Key Dates

Start date
Jan 26, 2021
Status verified
Jun 2025
Primary completion
Apr 8, 2024
Completion
Apr 14, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 50 Gray (Gy) Radiation Therapy with Concurrent Atezolizumab
    50 Gy of ionizing radiation therapy will be administered in 15 fractions.
  • Experimental: 50 Gray (Gy) Radiation Therapy
    50 Gy of ionizing radiation therapy will be administered in 15 fractions.
  • Experimental: 55 Gray (Gy) Radiation Therapy
    55 Gy of ionizing radiation therapy will be administered in 15 fractions.
  • Experimental: 60 Gray (Gy) Radiation Therapy
    60 Gy of ionizing radiation therapy will be administered in 15 fractions.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities at 50 Gy With Concurrent Atezolizumab [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & Medical College of WisconsinMilwaukeeWisconsin53226-

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