NCT04870840

Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer

Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).

Detailed description

PRIMARY OBJECTIVE: I. To assess the safety \& feasibility of image guided mid-treatment hyper-fractioned dose-escalation with proton therapy and identify the maximum tolerable dose (MTD) for the treatment of locally advanced human papillomavirus (HPV) negative head and neck cancer. OUTLINE: Patients undergo radiation therapy once daily (QD) 5 days a week (Monday through Friday) for the first 18 days and then twice daily (BID) for 15 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 8 weeks, 3, 6, 9, and 12 months in the first year after radiation therapy, every 4 months in the second year after radiation therapy, and then every 9 months thereafter.

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
• Locally Advanced Laryngeal Squamous Cell Carcinoma
• Locally Advanced Nasopharyngeal Squamous Cell Carcinoma
• Locally Advanced Oral Cavity Squamous Cell Carcinoma
• Locally Advanced Oropharyngeal Squamous Cell Carcinoma
• Malignant Posterior Tongue Neoplasm
• Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
• Stage II Hypopharyngeal Carcinoma AJCC v8
• Stage II Laryngeal Cancer AJCC v8
• Stage II Nasopharyngeal Carcinoma AJCC v8
• Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
• Stage III Hypopharyngeal Carcinoma AJCC v8
• Stage III Laryngeal Cancer AJCC v8
• Stage III Nasopharyngeal Carcinoma AJCC v8
• Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Unresectable Head and Neck Squamous Cell Carcinoma
• Unresectable Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Proton Beam Radiation Therapy	Undergo radiation therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-10-19
• Primary completion: 2023-07-11
• Completion: 2023-07-11
• First posted: 2021-05-04
• Last updated: 2024-10-29

Locations

1 site across 1 country: United States