Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensity-modulated radiotherapy, Magnetic Resonance Guidance.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma, Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 2 Trial of Adaptive Radiotherapy Boost for Head and Neck Squamous Cell Carcinomas
Overview
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.
Interventions
- Radiation Intensity-modulated radiotherapy
All patients will be treated with intensity-modulated radiotherapy (IMRT) plans. - Other Magnetic Resonance Guidance
All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.
Primary outcome measures
- Improvement in Mean OAR Dose Reduction [Time frame: Up to 15 months]
Secondary outcome measures (2)
- Percentage of patients achieving a complete anatomic response [Time frame: Up to 15 months]
- Percentage of patients achieving a complete metabolic response [Time frame: Up to 15 months]
Eligibility criteria
Inclusion criteria
- 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.
- 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
- 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
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Identifiers
NCT: NCT06137274 · MCC-22313