Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
- Locally Advanced Laryngeal Squamous Cell Carcinoma
- Unresectable Oropharyngeal Squamous Cell Carcinoma
- Locally Advanced Nasopharyngeal Squamous Cell Carcinoma
- Locally Advanced Oral Cavity Squamous Cell Carcinoma
- Unresectable Head and Neck Squamous Cell Carcinoma
- Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Locally Advanced Oropharyngeal Squamous Cell Carcinoma
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Malignant Posterior Tongue Neoplasm
- Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage III Nasopharyngeal Carcinoma AJCC v8
- Stage II Hypopharyngeal Carcinoma AJCC v8
- Stage II Laryngeal Cancer AJCC v8
- Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage II Nasopharyngeal Carcinoma AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04870840
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Clifton D Fuller M.D. Anderson Cancer Center
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