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Adaptive Radiotherapy for Head and Neck Cancer (DEHART Trial)

Phase 1
Recruiting
Led By Musaddiq Awan, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Zubrod performance status 0-3
1. Not a candidates for concurrent, bolus, cisplatin-based chemoradiation therapy based on one of the following criteria (a-e)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

DEHART Trial Summary

This trial is testing a new way of giving radiation to people with head and neck squamous cell carcinoma that uses MRgRT to adapt the radiation dose based on tumor response.

Who is the study for?
Adults aged 18+ with advanced head and neck squamous cell carcinoma, not suitable for standard chemotherapy due to age or health issues. Participants must have a specific level of organ function, no severe allergies to atezolizumab, and agree to use contraception if applicable. Excluded are those with certain recent illnesses, transplants, infections like HIV/HBV/HCV unless controlled, severe lung disease requiring oxygen therapy, or who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial tests adaptive radiotherapy doses alongside the drug atezolizumab in patients with head and neck cancer. The radiation dose is adjusted based on tumor response using MRgRT technology—increasing where the tumor persists and decreasing where it regresses—to improve outcomes while minimizing side effects.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation therapy such as skin irritation and fatigue; atezolizumab may cause immune-related effects like inflammation in organs or infusion reactions. Each patient's experience can vary.

DEHART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but may not be able to do heavy physical work.
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I cannot have cisplatin-based chemoradiation due to specific health reasons.
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I am 18 years old or older.
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My cancer has returned after surgery meant to remove it.
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I am not eligible for specific chemotherapy with radiation due to certain conditions.
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My blood counts meet the required levels for treatment.
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I refuse to undergo treatment with cisplatin-based chemoradiation.
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I am 18 years old or older.
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My liver tests are within normal limits.
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I am under 70 and have severe health issues making me sensitive to certain cancer treatments.
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My cancer is a specific type of head or neck cancer and can be measured.
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I am 18 or older with advanced squamous cell carcinoma in the head or neck.
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I have a measurable tumor in my head or neck.
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My G-8 health score is 14 or less.

DEHART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Dose-Limiting Toxicities at 50 Gy
Incidence of Dose-Limiting Toxicities at 55 Gy
Incidence of Dose-Limiting Toxicities at 60 Gy
+1 more
Secondary outcome measures
Gross Tumor Volume at Radiation Fraction 11 (Change from Baseline)
Gross Tumor Volume at Radiation Fraction 6 (Change from Baseline)
Locoregional progression
+1 more

DEHART Trial Design

3Treatment groups
Experimental Treatment
Group I: 60 Gray (Gy) Radiation TherapyExperimental Treatment2 Interventions
60 Gy of ionizing radiation therapy will be administered in 15 fractions.
Group II: 55 Gray (Gy) Radiation TherapyExperimental Treatment2 Interventions
55 Gy of ionizing radiation therapy will be administered in 15 fractions.
Group III: 50 Gray (Gy) Radiation TherapyExperimental Treatment2 Interventions
50 Gy of ionizing radiation therapy will be administered in 15 fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,723 Total Patients Enrolled
16 Trials studying Head and Neck Neoplasms
479 Patients Enrolled for Head and Neck Neoplasms
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,617 Total Patients Enrolled
314 Trials studying Head and Neck Neoplasms
46,373 Patients Enrolled for Head and Neck Neoplasms
Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,493 Total Patients Enrolled
7 Trials studying Head and Neck Neoplasms
8,131 Patients Enrolled for Head and Neck Neoplasms

Media Library

50 Gy Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04477759 — Phase 1
Head and Neck Neoplasms Research Study Groups: 50 Gray (Gy) Radiation Therapy, 55 Gray (Gy) Radiation Therapy, 60 Gray (Gy) Radiation Therapy
Head and Neck Neoplasms Clinical Trial 2023: 50 Gy Radiation Therapy Highlights & Side Effects. Trial Name: NCT04477759 — Phase 1
50 Gy Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04477759 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies do doctors commonly utilize 50 Gy Radiation Therapy to treat?

"50 Gy Radiation Therapy is often employed to treat small cell lung cancer (SCLC), yet it can be beneficial in the management of other malignant neoplasms, non-small cell lung carcinoma, and postoperative states."

Answered by AI

What implications does 50 Gy Radiation Therapy have on patient health?

"Although there is limited evidence to support the safety and efficacy of 50 Gy Radiation Therapy, Power experts have given it a score of 1."

Answered by AI

How many subjects are taking part in this experiment?

"Affirmative, the information on clinicaltrials.gov indicates that this trial is actively searching for participants. The study was initially posted in January 2021 and updated most recently in April 2022, with a recruitment goal of 18 patients at one site."

Answered by AI

Does this research endeavor still accept new participants?

"Affirmative. According to data on clinicaltrials.gov, this investigation is in its recruitment phase and was originally posted on January 26th of 2021 with a recent update conducted April 21st 2022. The study looks for 18 individuals at 1 centre."

Answered by AI

What benefits are expected to be derived from this experiment?

"The primary outcome of this 12-month medical trial is to determine the Maximum Tolerated Radiation Dose. Secondary endpoints include scores derived from questions related to taste, dysphagia, and skin pain/burning/rash on the MD Anderson Symptom Inventory tool."

Answered by AI

Is this the inaugural trial of its type?

"At present, there are 350 active trials for the 50 Gy Radiation Therapy procedure worldwide. It all began in 2008 when Hoffmann-La Roche conducted a Phase 2 drug approval trial with 720 patients across 74 countries and 1646 cities. 81 additional trials have been performed since then."

Answered by AI
~3 spots leftby Dec 2024