Your session is about to expire
← Back to Search
Adaptive Radiotherapy for Head and Neck Cancer (DEHART Trial)
Phase 1
Waitlist Available
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)
Must not have
Major surgery within 28 days prior to registration
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but may not be able to do heavy physical work.
Select...
I cannot have cisplatin-based chemoradiation due to specific health reasons.
Select...
My cancer has returned after surgery meant to remove it.
Select...
I am not eligible for specific chemotherapy with radiation due to certain conditions.
Select...
My blood counts meet the required levels for treatment.
Select...
I refuse to undergo treatment with cisplatin-based chemoradiation.
Select...
I am 18 years old or older.
Select...
My liver tests are within normal limits.
Select...
I am under 70 and have severe health issues making me sensitive to certain cancer treatments.
Select...
My cancer is a specific type of head or neck cancer and can be measured.
Select...
I am 18 or older with advanced squamous cell carcinoma in the head or neck.
Select...
I have a measurable tumor in my head or neck.
Select...
My G-8 health score is 14 or less.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 28 days.
Select...
I haven't had major heart issues or strokes in the last 3 months.
Select...
My cancer cannot be fully covered by a 19 cm treatment area in MR LINAC therapy.
Select...
I have had an allergic reaction to atezolizumab or its ingredients.
Select...
I have not received a live vaccine in the last 30 days.
Select...
I have not received any live vaccines in the last 4 weeks and will not during or for 5 months after my treatment.
Select...
I have had a stem cell or organ transplant from another person.
Select...
I have a serious gut condition that causes ongoing diarrhea.
Select...
My calcium levels are not higher than normal and I don't have symptoms of high calcium.
Select...
I have or had an autoimmune disease or immune deficiency.
Select...
I am currently on medication for hepatitis B.
Select...
I have previously been treated with specific immune therapies.
Select...
My body weight is 30 kg or less.
Select...
I haven't had a severe infection or been hospitalized for one in the last 4 weeks.
Select...
I have received chemotherapy, targeted therapy, or immunotherapy for my cancer.
Select...
I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.
Select...
I am not pregnant, not breastfeeding, and willing to use contraception during and 6 months after treatment.
Select...
I am currently hospitalized due to a respiratory illness.
Select...
I have a severe lung condition that needed or will need oxygen therapy in the last year.
Select...
I have Type 1 diabetes that is managed with insulin.
Select...
I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 3 months.
Select...
I have not had cancer, except for skin or early prostate cancer, in the last 3 years.
Select...
I am allergic to some chemotherapy drugs.
Select...
I have had leptomeningeal disease.
Select...
I have noticeable yellowing of my skin or eyes or known blood clotting issues.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
My high blood pressure is not under control.
Select...
I have an irregular heartbeat that is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Gross Tumor Volume at Radiation Fraction 11 (Change from Baseline)
Gross Tumor Volume at Radiation Fraction 6 (Change from Baseline)
Locoregional progression
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~5860
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,559 Previous Clinical Trials
569,436 Total Patients Enrolled
16 Trials studying Head and Neck Neoplasms
479 Patients Enrolled for Head and Neck Neoplasms
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,983 Total Patients Enrolled
318 Trials studying Head and Neck Neoplasms
46,300 Patients Enrolled for Head and Neck Neoplasms
Medical College of WisconsinLead Sponsor
631 Previous Clinical Trials
1,181,938 Total Patients Enrolled
7 Trials studying Head and Neck Neoplasms
8,131 Patients Enrolled for Head and Neck Neoplasms
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced severe side effects from cancer treatment, as measured by the CARG toxicity score.I have cancer spread that might cause pain or disability but hasn't yet.I have not had major surgery in the last 28 days.You have multiple chronic illnesses and your CIRS-G score is 4 or higher.You have other medical conditions besides the one being studied, which have been evaluated using a specific tool called ACE-27, and your score is 1 or higher.I can take care of myself but may not be able to do heavy physical work.You have a low score on the Geriatric 8 (G-8) test, which measures your ability to function independently.I have tested negative for HIV, or if positive, I am stable on treatment with good immune function and undetectable viral load.I cannot have cisplatin-based chemoradiation due to specific health reasons.My cancer has returned after surgery meant to remove it.You can undergo several MRI scans without any discomfort.My blood thinner medication dose has been stable.I haven't had major heart issues or strokes in the last 3 months.My cancer cannot be fully covered by a 19 cm treatment area in MR LINAC therapy.I have had an allergic reaction to atezolizumab or its ingredients.I have not received a live vaccine in the last 30 days.I have not received any live vaccines in the last 4 weeks and will not during or for 5 months after my treatment.I have had a stem cell or organ transplant from another person.I have a serious gut condition that causes ongoing diarrhea.My calcium levels are not higher than normal and I don't have symptoms of high calcium.I have or had an autoimmune disease or immune deficiency.I haven't taken antibiotics for treatment in the last 2 weeks, only for prevention.I have an autoimmune thyroid condition but am on medication for it.I am currently on medication for hepatitis B.I have previously been treated with specific immune therapies.I agree to use effective contraception or practice true abstinence as per the study's requirements.I have or had an autoimmune or inflammatory disorder but may qualify under certain exceptions.I haven't used strong immune system suppressing drugs in the last 14 days, except for small doses of corticosteroids or specific exceptions.My body weight is 30 kg or less.I haven't had a severe infection or been hospitalized for one in the last 4 weeks.I do not have an active infection like TB, hepatitis B, or hepatitis C.I have received chemotherapy, targeted therapy, or immunotherapy for my cancer.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I am over 70 and have health issues that make cisplatin risky for me.I am a woman who is either postmenopausal, surgically sterile, or willing to use two forms of contraception.I am not pregnant, not breastfeeding, and willing to use contraception during and 6 months after treatment.My skin condition is stable, affects less than 10% of my body, and I haven't needed strong treatments in the last year.I am not eligible for specific chemotherapy with radiation due to certain conditions.My blood counts meet the required levels for treatment.I am currently hospitalized due to a respiratory illness.I have a severe lung condition that needed or will need oxygen therapy in the last year.I have Type 1 diabetes that is managed with insulin.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 3 months.I refuse to undergo treatment with cisplatin-based chemoradiation.I have had radiation therapy to my head or neck, but not external beam radiotherapy.I don't have any health issues that would make it unsafe for me to take a new drug.I have not had cancer, except for skin or early prostate cancer, in the last 3 years.Your ω score needs to be above 0.80.I am 18 years old or older.My liver tests are within normal limits.I am under 70 and have severe health issues making me sensitive to certain cancer treatments.My cancer is a specific type of head or neck cancer and can be measured.I am 18 or older with advanced squamous cell carcinoma in the head or neck.I have a measurable tumor in my head or neck.I am mentally and physically able to follow the study's requirements.I had a major heart attack in the last 3 months.You have one or more chronic medical conditions, as determined by a healthcare provider.Your ACE-27 Index score is equal to or greater than 1.I am allergic to some chemotherapy drugs.I have had leptomeningeal disease.I have noticeable yellowing of my skin or eyes or known blood clotting issues.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.You have a foreign object in your body that is not safe for use during an MRI scan.I have had pneumonitis treated with steroids or have it now.You have a pacemaker or implantable cardioverter defibrillator (ICD) that is not compatible with an MRI scan.My high blood pressure is not under control.Your doctor expects you to live for less than a year.I have an irregular heartbeat that is not under control.My G-8 health score is 14 or less.You have a cochlear implant.You are afraid of closed spaces, which would make it hard for you to handle multiple MRI scans.I don't need frequent procedures to remove excess fluid in my body.
Research Study Groups:
This trial has the following groups:- Group 1: 50 Gray (Gy) Radiation Therapy
- Group 2: 55 Gray (Gy) Radiation Therapy
- Group 3: 60 Gray (Gy) Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger