Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma
A Non-Randomized, Open-Label, Multi-Center Pilot Study Evaluating Hypofractionation Radiation Therapy in Head and Neck Squamous Cell Carcinoma
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.
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
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
Number of participants with Locoregional Control (LRC)
Overall Survival (OS) rate
Head and Neck Squamous Cell Carcinoma (HNSCC)
Study Arms / Comparison Groups
Adjuvant Hypofractionated Radiation Treatment
Description: Short course radiation therapy for patients who have undergone surgery
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
July 3, 2019
Primary Completion Date
- Age ≥ 70 years.
- No previous RT or chemotherapy for HNSCC is allowed at time of study entry.
- Life expectancy > 12 weeks.
- Participants must have histologically or cytologically confirmed diagnosis of HNSCC:
oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown
- All stages (according to National Comprehensive Cancer Network 8th edition for head
and neck cancers), except stage IVC5
- Non-concurrent chemotherapy
- First line treatment
- Anyone eligible for definitive or adjuvant based RT therapy
- Adjuvant therapy when histopathological factors (advanced T category, nodal disease,
lymphovascular or perineural invasion, high-grade, or positive margins)
- Anyone being treated with curative intent
- Unfit as determined by the treating physician and ECOG performance 1, 2, or 3
- Ability to understand and the willingness to sign a written informed consent.
- Patients < 70
- Metastatic disease outside of the head and neck
- Previous or current malignancies at other sites, with the exception of adequately
treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin,
thyroid cancer, or other cancer curatively treated by surgery and with no current
evidence of disease for at least 5 years.
- Prior RT of head and neck area
- Concurrent chemotherapy or immunotherapy or hormonotherapy
- Any comorbid connective tissue disorder which could aggravate RT associated toxicities
- In cases where patients cannot consent on their own due to underlying dementia, we can
consent the patient's healthcare proxy