Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Registration Number
- NCT04284540
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers in patients 70 years of age and older.
Standard radiation treatment for head and neck patients normally requires that the patient travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. If this happens, and there are gaps in the radiation treatment, this can lead to worse outcomes.
- Detailed Description
This is a non-randomized pilot study examining the objective response rate and tolerability of short-course radiotherapy (RT) in elderly patients who are unfit for standard conventional fractionation treatment with head and neck squamous cell carcinoma (HNSCC). There will be two unrelated cohorts in this study: definitive RT and adjuvant RT. Patients will be assigned to the cohorts based on their surgical or non-surgical candidacy. The primary study measure is the locoregional control (LRC) rate of patients at 6 months post RT treated with short-course RT. Locoregional control at one year will be determined by radiographic (PET/CT) and clinical assessment of disease. For the definitive cohort, LRC will be defined as regression in size or disappearance of primary tumor and/or lymph nodes on imaging or clinical examination; and for the adjuvant cohort, LRC will be defined as absence of disease on imaging or no clinical evidence of disease.
To further investigate the treatment regimen, the study team will assess the safety of short-course RT and determine the incidence of serious complications, overall survival (OS), disease-free survival (DFS) within 1 year, and the change in quality of life (QoL) in these patients who are unfit for standard conventional fractionation treatment with head and neck squamous cell carcinoma (HNSCC) as secondary objectives. Secondary endpoints will include 1- year overall survival (OS), 1-year disease-free survival (DFS), and the total score of the Functional Assessment of Cancer Therapy-Head and Neck questionnaire (FACT-H\&N). DFS will be defined from the completion of treatment until disease recurrence locally, regionally and/or distantly or until death from disease. OS will be defined from the RT to death or to last follow-up.
As a safety endpoint, the study team will calculate number and proportion of patients developing reportable AEs and SAEs according to relatedness to the treatment and stratified by severity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants with Locoregional Control (LRC) 6 months For the adjuvant cohort: LRC will be defined as absence of disease on imaging or no clinical evidence of disease. For the definitive cohort: LRC will be defined as regression in size or disappearance of primary tumor and/or lymph nodes on imaging or clinical examination.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) rate 1 year 1 year overall survival of patients as defined by completion of treatment until death at 1 year.
Disease Free Survival (DFS) rate 1 year 1 year disease free survival of patients as defined by completion of treatment until disease recurrence locally, regionally and/or distantly or until the time of death due to disease assessed via PET scan and physical exam.
University of Washington Quality of Life Questionnaire (UW-QOL) Up to 3 years University of Washington Quality of Life Questionnaire (UW-QOL) full scale from 0 to 100, with higher score indicating poorer health outcomes.
FACT-H&N questionnaire Up to 1 year Foundation for the Accreditation of Cellular Therapy-Head and Neck (FACT-H\&N) questionnaire, 38-item instrument. Full scale from 0 to 144, with higher score indicating better quality of life.
Trial Locations
- Locations (4)
Mount Sinai Downtown Union Square
🇺🇸New York, New York, United States
Mount Sinai Chelsea
🇺🇸New York, New York, United States
Mount Sinai West
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Mount Sinai Downtown Union Square🇺🇸New York, New York, United States