Daily Adaptive Radiotherapy for Squamous Cell Carcinoma
(RTL-DART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of delivering radiation therapy for head and neck cancer. The goal is to determine if daily adaptive radiation therapy, which adjusts treatment daily using advanced imaging, can better protect the salivary glands compared to standard radiation therapy. Participants will receive either the usual radiation therapy or the new adaptive radiation therapy. This trial suits individuals with squamous cell carcinoma in the head or neck area who are scheduled for curative radiation treatment. As an unphased trial, it provides a unique opportunity to contribute to innovative research that may enhance future cancer treatments.
What prior data suggests that daily adaptive radiotherapy is safe for head and neck cancer patients?
Research has shown that daily adaptive radiation therapy (ART) is generally well-tolerated by patients with head and neck squamous cell carcinoma. Studies have found that ART can be used safely, with manageable side effects. One study showed that ART led to better safety outcomes compared to traditional methods, resulting in fewer negative effects while maintaining treatment effectiveness.
Additionally, trials have tested ART without revealing any unusual or severe side effects. The evidence suggests that the treatment is safe and effective, with a 3-year survival rate similar to other treatments. While no treatment is completely without risk, research supports the safety of daily adaptive radiation therapy for head and neck cancer.12345Why are researchers excited about this trial?
Researchers are excited about daily adaptive radiation therapy for squamous cell carcinoma because it offers a personalized approach to treatment. Unlike traditional radiation therapy, which follows a fixed plan over several weeks, this innovative method uses AI to adapt the radiation dose daily based on changes in the patient's anatomy. This tailored approach aims to target the cancer more precisely while minimizing damage to surrounding healthy tissues, potentially improving effectiveness and reducing side effects.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
This trial will compare Daily Adaptive Radiation Therapy (ART) with Image Guided Radiation Therapy (IGRT) for treating head and neck squamous cell carcinoma (HNSCC). Studies have shown that ART can effectively treat HNSCC. Research indicates that ART works well and is safe because it precisely targets the tumor. In one study, 80.5% of patients had a complete response at their first follow-up after treatment. This finding suggests that ART might better protect healthy tissue while still attacking cancer cells. Additionally, ART is practical and allows for daily changes to the treatment plan, potentially leading to better patient outcomes.16789
Are You a Good Fit for This Trial?
This trial is for individuals with squamous cell carcinoma in the head and neck region. Specific details about eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a diagnosis that aligns with the study's focus.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline functional CT scan and assessments including oral and dental assessment, PSS-HNC swallow assessment, unstimulated salivary flow rate test, DMFS160 index, and quality of life questionnaire
Treatment
Participants receive radiation treatment for approximately 7 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment with assessments at 1.5, 6, 12, and 24 months
What Are the Treatments Tested in This Trial?
Interventions
- Daily Adaptive Radiation Therapy
- Image Guided Radiation Therapy
Trial Overview
The study compares two types of radiation therapy: standard Image Guided Radiation Therapy (IGRT) versus Daily Adaptive Radiotherapy (ART). The goal is to see if ART can better spare the submandibular gland from damage during treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Structures of daily adaptive radiation therapy organ at risk will be AI generated in the Ethos platform on the daily CBCT and then edited by radiation therapy team as required. A rigid registration of CTV targets to the CBCT replicating the current radiation therapy led IGRT process.
This arm will proceed as per the standard of care. The pre-treatment reference plan will be delivered daily for 35 fractions. If a notable change in anatomy is identified, a dose of the day calculation may be performed as per current standard head and neck workflow
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Citations
results of the DARTBOARD phase II randomized trial
The utility of adaptive radiotherapy (ART) for head and neck squamous cell carcinoma (HNSCC) remains poorly defined. Daily ART (DART) ...
2.
onclive.com
onclive.com/view/daily-adaptive-radiotherapy-delivers-improved-efficacy-and-safety-outcomes-in-hnsccDaily Adaptive Radiotherapy Delivers Improved Efficacy ...
Daily adaptive radiotherapy with 1-mm planning target volume margins is feasible in patients with head and neck squamous cell carcinoma.
Acute Toxicity and Efficiency Outcomes in the ...
The gross tumor volume (GTV) received 70 Gy, the primary clinical target volume (CTV) and suspicious nodes received 63 Gy, and nodes on the same level as nodal ...
Acute Toxicity and Efficiency Outcomes in the ...
The gross tumor volume (GTV) received 70 Gy, the primary clinical target volume (CTV) and suspicious nodes received 63 Gy, and nodes on the same level as nodal ...
Clinical outcomes of adaptive radiotherapy in head and ...
36 patients were evaluable at 6–8 weeks after completion of treatment. 29 (80.5%) patients achieved complete response at first follow-up. Five patients had ...
Does adaptive radiotherapy for head and neck cancer ...
Their results indicated a 3-year locoregional failure-free survival (LRFS) rate of 72.7% in the ART group compared with 68.1% in the non-ART ...
Impact of daily adaptive head and neck radiotherapy on ...
Impact of daily adaptive head and neck radiotherapy on toxicity and quality of life: results of the DARTBOARD phase II randomized trial ; Received: 22 April 2025.
Contour uncertainty assessment for MD-omitted daily ...
This study shows that DIR can effectively propagate periodically edited treatment contours for HNSCC patients, provided the correct CM is used. By adjusting ...
Weekly Adaptive Radiotherapy vs Standard Intensity ...
Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data.
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