Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCC

NCT06137274 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: MCC-22313
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.

Conditions

Squamous Cell Carcinoma; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of patients achieving a complete anatomic response

  Up to 15 months

• Percentage of patients achieving a complete metabolic response

  Up to 15 months

Study Arms (1)

Adaptive Radiotherapy treatment

EXPERIMENTAL

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.

Radiation: Intensity-modulated radiotherapy; Other: Magnetic Resonance Guidance

Interventions

Intensity-modulated radiotherapy RADIATION

All patients will be treated with intensity-modulated radiotherapy (IMRT) plans.

Also known as: IMRT

Adaptive Radiotherapy treatment

Magnetic Resonance Guidance OTHER

All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.

Also known as: View Ray

Adaptive Radiotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• George Yang, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Brennaman

CONTACT

813-745-5467; ashley.brennaman@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)