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Trial Title:
Pilot Trial of Adaptive Radiotherapy Boost for HNSCC
NCT ID:
NCT06137274
Condition:
Squamous Cell Carcinoma
Head and Neck Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiotherapy
Description:
All patients will be treated with intensity-modulated radiotherapy (IMRT) plans.
Arm group label:
Adaptive Radiotherapy treatment
Other name:
IMRT
Intervention type:
Other
Intervention name:
Magnetic Resonance Guidance
Description:
All patients will undergo combined CT and/or MR simulation and will be treated with a
sequential-boost technique.
Arm group label:
Adaptive Radiotherapy treatment
Other name:
View Ray
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 . The technique under study will be used to personalize the study
treatment based on response, keeping all treatments within standard of care guidelines.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kevin Samnarine
Phone:
813-745-4245
Email:
kevin.Samnarine@moffitt.org
Investigator:
Last name:
George Yang, MD
Email:
Principal Investigator
Start date:
December 18, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06137274
