Head and Neck Squamous Cell Carcinoma (HNSCC)NCT04284540
Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma
A study testing Adjuvant hypofractionation and Definitive Hypofractionation in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- What is being tested?
- Adjuvant hypofractionation and Definitive Hypofractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2019to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 primary)
- All stages (according to National Comprehensive Cancer Network 8th edition for head and neck cancers), except stage IVC5
- Non-concurrent chemotherapy
Show all 12Show fewer
- 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 (Appendix 2).
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Patients < 70
- Metastatic disease outside of the head and neck
- Pregnancy
- 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 (e.g. Scleroderma)
- In cases where patients cannot consent on their own due to underlying dementia, we can consent the patient's healthcare proxy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mount Sinai Downtown Union Square
New York, New York, 10003
Mount Sinai Chelsea
New York, New York, 10011
Mount Sinai West
New York, New York, 10019
Mount Sinai Hospital
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Being tested
- Adjuvant hypofractionation, Definitive Hypofractionation
- Keywords
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Radiotherapy, Over 70 years of age, Elderly, shorter course of radiation treatment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant hypofractionationRadiation
15 fractions of 2.7 Gy per fraction daily over 3 weeks for a total of 40.5 Gy to the post-operative bed and/or necks.
Definitive HypofractionationRadiation
15 fractions of 3 Gy per fraction daily over 3 weeks for a total of 45 Gy to regions of gross disease. Elective areas can be treated to 37.5 Gy in 15 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Hypofractionated Radiation Treatment | Experimental | Short course radiation therapy for patients who have undergone surgery Receives: Radiation: Adjuvant hypofractionation |
| Definitive Hypofractionated Radiation Treatment | Experimental | Short course radiation therapy for patients who have not had surgery Receives: Radiation: Definitive Hypofractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Locoregional Control (LRC)
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.
Measured: 6 months
Secondary outcomes (4)
Overall Survival (OS) rate
1 year overall survival of patients as defined by completion of treatment until death at 1 year.
Measured: 1 year
Disease Free Survival (DFS) rate
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.
Measured: 1 year
University of Washington Quality of Life Questionnaire (UW-QOL)
University of Washington Quality of Life Questionnaire (UW-QOL) full scale from 0 to 100, with higher score indicating poorer health outcomes.
Measured: Up to 3 years
FACT-H&N questionnaire
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Jul 2019
- Primary completion7 Nov 2024
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard L. Bakst, Icahn School of Medicine at Mount Sinai
- Investigators
- Richard L. Bakst, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284540
- Sponsor's protocol ID
- GCO 19-0499
- Status last verified
- Jan 2026
- First submitted
- 24 Feb 2020
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label, Multi-Center Pilot Study Evaluating Hypofractionation Radiation Therapy in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04284540
- Acronym / sponsor ID
- GCO 19-0499
- Keywords
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Radiotherapy, Over 70 years of age, Elderly, shorter course of radiation treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Hypofractionated Radiation Treatment | Experimental | Radiation: Adjuvant hypofractionationShort course radiation therapy for patients who have undergone surgery |
| Definitive Hypofractionated Radiation Treatment | Experimental | Radiation: Definitive HypofractionationShort course radiation therapy for patients who have not had surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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 primary)
- All stages (according to National Comprehensive Cancer Network 8th edition for head and neck cancers), except stage IVC5
Key exclusion criteria (8 listed)
- Patients < 70
- Metastatic disease outside of the head and neck
- Pregnancy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant hypofractionation15 fractions of 2.7 Gy per fraction daily over 3 weeks for a total of 40.5 Gy to the post-operative bed and/or necks. | Radiation | Adjuvant Hypofractionated Radiation Treatment |
| Definitive Hypofractionation15 fractions of 3 Gy per fraction daily over 3 weeks for a total of 45 Gy to regions of gross disease. Elective areas can be treated to 37.5 Gy in 15 fractions. | Radiation | Definitive Hypofractionated Radiation Treatment |
Primary outcome
Number of participants with Locoregional Control (LRC)
Time frame: 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.
4 secondary outcomes
Overall Survival (OS) rate
Time frame: 1 year
Disease Free Survival (DFS) rate
Time frame: 1 year
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: Up to 3 years
FACT-H&N questionnaire
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard L. Bakst, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant hypofractionation and Definitive Hypofractionation in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Locoregional Control (LRC) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.