Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04870840|
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]|
|Actual Study Start Date :||October 19, 2020|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Treatment (proton therapy)
Patients undergo radiation therapy QD 5 days a week (Monday through Friday) for the first 18 days and then BID for 15 days in the absence of disease progression or unacceptable toxicity.
Radiation: Proton Beam Radiation Therapy
Undergo radiation therapy
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Incidence of severe unacceptable local adverse events which are radio therapeutically attributable [ Time Frame: Up to 6 months after radiation therapy ]Specifically, Common Terminology Criteria for Adverse Events (CTCAE) version 5 grade 4 mucositis, dermatitis or aspiration that does not resolve to a grade =< 3 in 3 months, and CTCAE version 5 grade >= 3 myelopathy, and/or osteonecrosis. Summary statistics, including mean, standard deviation and 95% confidence interval will be used to describe safety data. Toxicity will be tabulated and summarized by grade and type.
- Incidence of grade 3 toxicity [ Time Frame: At 3-6 months after radiation therapy ]Specifically, CTCAE version 5 grade 3 mucositis, dermatitis, aspiration, dysphagia, hearing impaired, xerostomia, weight loss, trismus, hoarseness, oropharyngeal pain. Summary statistics, including mean, standard deviation and 95% confidence interval will be used to describe safety data. Toxicity will be tabulated and summarized by grade and type. Radiation induced side effect (RISE) rate will be summarized by frequency, standard deviation and 95% confidence interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870840
|Contact: Clifton D Fullerfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clifton D. Fuller 713-563-2300|
|Principal Investigator: Clifton D. Fuller|
|Principal Investigator:||Clifton D Fuller||M.D. Anderson Cancer Center|