Status:
ACTIVE_NOT_RECRUITING
Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCC
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Squamous Cell Carcinoma
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 . Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06137274
Start Date
December 14 2023
End Date
November 1 2026
Last Update
December 31 2025
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612