Pilot Trial of Adaptive Radiotherapy Boost for HNSCC

Not Applicable

Recruiting

• Conditions: Squamous Cell Carcinoma; Head and Neck Cancer

• Registration Number: NCT06137274
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Provision of signed and dated informed consent form<br><br> - Stated willingness to comply with all study procedures and availability for the<br> duration of the study<br><br> - ECOG performance status of 0, 1<br><br> - Patients with histologically or cytologically confirmed squamous cell carcinoma of<br> the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in<br> the neck.<br><br> - Patients with measurable disease, either at primary site or neck per RECIST 1.1.<br><br> - For patients planned to receive chemotherapy, adequate hematologic, hepatic and<br> renal function as outlined in protocol.<br><br> - International normalized ratio of prothrombin time (INR) and prothrombin time (PT)<br> within 28 days before randomization must be WNL for the lab. Patients who are<br> therapeutically treated with an agent such as warfarin may participate if they are<br> on a stable dose and no underlying abnormality in coagulation parameters exists per<br> medical history.<br><br> - Negative serum pregnancy test within before starting study treatment in woman with<br> childbearing potential.<br><br>Exclusion Criteria:<br><br> - Pregnancy or lactation<br><br> - Patients who have had prior radiotherapy to the head and neck or prior systemic<br> therapy for the index cancer.<br><br> - Patients who had undergone definitive surgery for the index cancer.<br><br> - Patients with distant metastatic disease<br><br> - Uncontrolled intercurrent illness including, but not limited to, ongoing or active<br> infection, or psychiatric illness/social situations that would limit compliance with<br> study requirements.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Mean OAR Dose Reduction

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving a complete anatomic response;Percentage of patients achieving a complete metabolic response