CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Concurrent Atezolizumab +4 moredrug
Likely dose
Concurrent Atezolizumab 1,680 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04477759
NCT04477759Phase 1Completed

A Phase I Trial of MR-Guided Dose-Escalated Hypofractionated Adaptive Radiation Therapy and Immunotherapy in Primary Metastatic or Very Locally Advanced Patients With Head and Neck Cancer

Medical College of Wisconsin·interventional·Posted Jul 20, 2020·Updated Jul 15, 2025

In Brief

A Phase 1 clinical trial evaluating 50 Gy Radiation Therapy, 55 Gy Radiation Therapy, and 3 other interventions for Head and Neck Neoplasm. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 20, 2020
Enrollment StartJan 26, 2021
Primary CompletionApr 8, 2024
Study CompletionApr 14, 2025
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.0 years ago

Interventions

50 Gy Radiation Therapyradiation

Ionizing radiation

55 Gy Radiation Therapyradiation

Ionizing radiation

60 Gy Radiation Therapyradiation

Ionizing radiation

Concurrent Atezolizumabdrug

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 Atezolizumabdrug

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.