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

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).

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

RADIATION

Proton Beam Radiation Therapy

Undergo radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Clifton D Fuller · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-19

Primary Completion

2023-07-11

Completion

2023-07-11

Countries

• United States

Study Locations