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NCT04477759 · ClinicalTrials.gov registry record · Phase 1

Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer

A Phase 1 study of Head and Neck Neoplasm, sponsored by Medical College of Wisconsin.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT04477759 is a Phase 1 study of Head and Neck Neoplasm that has completed, run by Medical College of Wisconsin. The registered enrollment target is 18 participants, below the 175-participant average among 3 other Head and Neck Neoplasm trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04477759, a Phase 1 study of Head and Neck Neoplasm, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • RADIATION 50 Gy Radiation Therapy
  • RADIATION 55 Gy Radiation Therapy
  • RADIATION 60 Gy Radiation Therapy
  • DRUG Concurrent Atezolizumab
  • DRUG Adjuvant Atezolizumab

Study Locations (1)

Wisconsin

  • Froedtert & Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2021-01-26
Est. Completion 2025-04-14
Phase Phase 1

Sponsor

Medical College of Wisconsin

447 total trials

What the Registry Record Tells You About NCT04477759

The ClinicalTrials.gov registry entry for NCT04477759 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 175-participant average among 3 other Head and Neck Neoplasm trials with a reported enrollment target (90% lower). The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which 50 Gy Radiation Therapy is the first listed.

NCT04477759 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT04477759 about?

NCT04477759 is a clinical study titled "Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer". 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 th...

What is the current status of trial NCT04477759?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-01-26. Estimated completion is 2025-04-14.

What conditions does trial NCT04477759 study?

This clinical trial studies the following conditions: Head and Neck Neoplasm.

What interventions are being tested in trial NCT04477759?

The interventions under investigation include: 50 Gy Radiation Therapy (RADIATION), 55 Gy Radiation Therapy (RADIATION), 60 Gy Radiation Therapy (RADIATION), Concurrent Atezolizumab (DRUG), Adjuvant Atezolizumab (DRUG).

Who is sponsoring clinical trial NCT04477759?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04477759 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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