← Back to Search

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
All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

DARTBOARD Trial Summary

This trial will study whether using DART with ML setup margins can increase the rate of tumor control and/or reduce toxicity compared to using DART with standard margins.

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.Check my eligibility
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.See study design
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.

DARTBOARD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to use effective birth control during and for 90 days after the study.
Select...
I have been diagnosed with squamous cell carcinoma in my throat, but not from an unknown primary.
Select...
My cancer is between stages I and IVB, but it's not in the early stages of glottic cancer.
Select...
I am a woman capable of becoming pregnant.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
My cancer can be seen or measured on scans, or I've had a small biopsy.
Select...
I may have surgery through the mouth for early-stage cancer in my tonsil or base of tongue.
Select...
I am 18 years old or older.
Select...
I have not had my uterus or both ovaries removed.

DARTBOARD 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
Xerostomia
Secondary outcome measures
Development of acute and chronic toxicity in patients treated with and without DART
Patient reported outcomes
Risk of locoregional recurrence with and without DART

DARTBOARD 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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,038 Previous Clinical Trials
1,046,721 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

Frequently Asked Questions

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

How many participants are eligible to take part in this clinical research?

"Affirmative. Clinicaltrials.gov delineates that this clinical experiment, which was posted on February 23rd 2022, is currently recruiting participants. A total of 50 patients are needed to be recruited from one location."

Answered by AI

Is this experiment actively seeking new participants?

"Clinicaltrials.gov highlights that this medical study is actively looking for participants, having been posted to the platform on February 23rd 2022 and last edited on August 19th of the same year."

Answered by AI

Has the FDA granted approval to using Intensity modulated radiation therapy (IMRT) and/or chemotherapy?

"Our team at Power rated the safety of Intensity modulated radiation therapy with or without chemotherapy as a 2 on their scale, due to there being some evidence for safety but none for efficacy."

Answered by AI

In what medical scenarios is Intensity modulated radiation therapy (IMRT) combined with chemotherapy commonly employed?

"IMRT, often combined with chemotherapy, can be a successful treatment for malignant neoplasms and metastatic colorectal cancer (CRC) in patients that are intolerant to irinotecan."

Answered by AI
~5 spots leftby Jul 2024