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Adaptive Radiotherapy for Head and Neck Cancer (DEHART Trial)
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.
DEHART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDEHART Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DEHART Trial Design
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Who is running the clinical trial?
Media Library
- 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.I am 18 years old or older.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.
- Group 1: 50 Gray (Gy) Radiation Therapy
- Group 2: 55 Gray (Gy) Radiation Therapy
- Group 3: 60 Gray (Gy) Radiation Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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