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Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer

NCT04477759 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-15

Study results available
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Summary

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.

Conditions

  • Head and Neck Neoplasm

Interventions

RADIATION

50 Gy Radiation Therapy

Ionizing radiation

RADIATION

55 Gy Radiation Therapy

Ionizing radiation

RADIATION

60 Gy Radiation Therapy

Ionizing radiation

DRUG

Concurrent Atezolizumab

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.

DRUG

Adjuvant Atezolizumab

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Musaddiq Awan, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2024-04-08
Completion
2025-04-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477759 on ClinicalTrials.gov