Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2023-12-14
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adaptive Radiotherapy treatment
Patients will undergo adaptive radiotherapy boost for head/neck squamous cell carcinomas. A base conventional IMRT plan of 46-50Gy in 2 Gy to gross disease in the primary/nodes and 41.4-45 Gy in 1.8 Gy to the elective nodes per fraction will be utilized. The MR simulation will be utilized for boost treatment planning. Patients will receive their 6th fraction of the week on the adaptive platform treating the gross disease until completion of the base plan to 20 Gy in 2Gy daily fractions (10 fractions). Each ART treatment will be recontoured/replanned by the treating head/neck radiation oncologist as deemed clinically or dosimetrically necessary.
Intensity-modulated radiotherapy
All patients will be treated with intensity-modulated radiotherapy (IMRT) plans.
Magnetic Resonance Guidance
All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.
Interventions
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Intensity-modulated radiotherapy
All patients will be treated with intensity-modulated radiotherapy (IMRT) plans.
Magnetic Resonance Guidance
All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Patients with measurable disease, either at primary site or neck per RECIST 1.1.
* For patients planned to receive chemotherapy, adequate hematologic, hepatic and renal function as outlined in protocol.
* International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history.
* Negative serum pregnancy test within before starting study treatment in woman with childbearing potential.
Exclusion Criteria
* 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
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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George Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Other Identifiers
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MCC-22313
Identifier Type: -
Identifier Source: org_study_id