Pilot Trial of Adaptive Radiotherapy Boost for HNSCC

Head and Neck Cancer Clinical Trial

Official title:

Pilot Trial of Adaptive Radiotherapy Boost for Head and Neck Squamous Cell Carcinomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137274
• Other study ID #: MCC-22313
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: January 2027

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Amalin Asous
• Phone: 813-745-6470
• Email: Amalin.Asous[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 15 months
Secondary	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.	Up to 15 months
Secondary	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.	Up to 15 months