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Proton Beam Therapy

Adaptive Radiotherapy + Chemotherapy for Head and Neck Cancer (DARTBOARD Trial)

Phase 2
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
Must not have
Stage I and II glottic carcinoma.
Prior invasive malignancy with an expected disease-free interval of less than 3 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing a new radiation machine called EthosTM that adjusts to the patient's body for treating head and neck cancer. It aims to improve accuracy and reduce side effects by adapting the treatment plan based on regular imaging.

Who is the study for?
Adults diagnosed with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (excluding some stages and types) who are in good enough health to participate. Pregnant women can't join, nor can those with distant metastasis, prior chemo for this cancer type, severe allergies to similar drugs used here, certain immune conditions including HIV, or overlapping radiation treatment areas.
What is being tested?
This study tests a new radiation system called EthosTM that adapts daily based on patient anatomy changes. It's compared against standard therapy. The trial may include chemotherapy agents like cisplatin or cetuximab depending on the case. Participants will be randomly assigned to receive either adaptive radiotherapy with minimal setup margins or the current standard treatment.
What are the potential side effects?
Radiation therapy side effects often include skin irritation at the treatment site, fatigue, dry mouth/throat issues if treating head and neck cancers; chemotherapy might add nausea/vomiting and increased risk of infections due to lower blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with squamous cell carcinoma in my throat, but not from an unknown primary.
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My cancer is between stages I and IVB, but it's not in the early stages of glottic cancer.
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I can take care of myself and am up and about more than half of the day.
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My cancer can be seen or measured on scans, or I've had a small biopsy.
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I am 18 years old or older.
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I have not had my uterus or both ovaries removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is in the early stages and located in my vocal cords.
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I had cancer before, but it's expected to stay away for less than 3 years.
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I have a history of severe immune system problems, including HIV, or have had a transplant.
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I have had radiation in the same area as my current cancer.
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All of my cancer and affected lymph nodes have been surgically removed.
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My cancer has spread to distant parts of my body.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Xerostomia
Secondary study objectives
Development of acute and chronic toxicity in patients treated with and without DART
Patient reported outcomes
Risk of locoregional recurrence with and without DART

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapyExperimental Treatment2 Interventions
Patients in the ML/DART Arm will have their radiation plan adapted with every fraction. The adaptation process will be performed automatically on the Varian Ethos adaptive therapy software under the supervision of the treating physician.
Group II: Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapyActive Control2 Interventions
If a patient loses a significant amount of weight on treatment, or the tumor contour changes substantially, repeat CT simulation and re-planning is allowed in the CM arm. However, the gross tumor volume may not be reduced due to tumor shrinkage. The original extent of disease must be included in the replanned GTV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity modulated radiation therapy (IMRT) with or without chemotherapy
2022
Completed Phase 2
~50
cisplatin, cetuximab, or carboplatin-paclitaxel
2022
Completed Phase 2
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Head and Neck Cancers include radiation therapy, chemotherapy, and the novel EthosTM System (Daily Adaptive Radiotherapy - DART). Radiation therapy works by damaging the DNA of cancer cells, leading to their death. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, by interfering with their DNA replication or other critical cellular functions. The EthosTM System enhances traditional radiation therapy by allowing daily adjustments based on the patient's current anatomy, improving precision and reducing damage to surrounding healthy tissues. This is particularly important for Head and Neck Cancer patients as it can increase treatment effectiveness while minimizing side effects, leading to better overall outcomes.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,076 Previous Clinical Trials
1,056,299 Total Patients Enrolled

Media Library

Intensity modulated radiation therapy (IMRT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04883281 — Phase 2
Head and Neck Cancers Research Study Groups: Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapy, Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapy
Head and Neck Cancers Clinical Trial 2023: Intensity modulated radiation therapy (IMRT) Highlights & Side Effects. Trial Name: NCT04883281 — Phase 2
Intensity modulated radiation therapy (IMRT) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883281 — Phase 2
~14 spots leftby Oct 2025