Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
ECOG performance status of 0, 1
Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck.
Disqualifiers
Pregnancy or lactation
Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer.
Patients who had undergone definitive surgery for the index cancer.
Patients with distant metastatic disease
Trial design
Design model
Single group
Treatments tested in this trial
Intensity-modulated radiotherapy
RadiationAll patients will be treated with intensity-modulated radiotherapy (IMRT) plans.
Magnetic Resonance Guidance
Other interventionAll patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Adaptive Radiotherapy treatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Improvement in Mean OAR Dose Reduction
Feasibility of MR adaptive boost technique, as defined as achieving a reduction of mean OAR (parotids, submandibular glands, pharynx, oral cavity, tubarial glands, larynx, esophagus, and thyroid) doses greater than 7.5% compared to unadapted CT based plan. If 18 of 25 patients are meet the mean OAR criteria the approach will be considered feasible.
Time frame
Up to 15 monthsSecondary outcomes
1
Percentage of patients achieving a complete anatomic response
Percentage of patients achieving a complete anatomic response by CT Neck and Chest and/or PET/CT will be tabulated. The 95% CI by the exact binomial distribution will be reported.
Time frame
Up to 15 months2
Percentage of patients achieving a complete metabolic response
Percentage of patients achieving a complete metabolic response by CT Neck and Chest and/or PET/CT will be tabulated. The 95% CI by the exact binomial distribution will be reported.
Time frame
Up to 15 monthsSponsors and contacts
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Source ClinicalTrials.gov