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3-Week radiation blast could spare seniors from 7 weeks of treatment

NCT ID NCT04284540

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a shorter radiation schedule (3 weeks instead of 6-7) for head and neck cancer in people aged 70 and older. The goal was to see if it could still control the cancer while reducing side effects and treatment gaps. 37 participants received either adjuvant or definitive hypofractionated radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy (hypofractionation)
What this could lead to
If successful, this shorter radiation schedule could make treatment easier for older patients and reduce side effects while still controlling the cancer.
What could go wrong
This is a small pilot study with only 37 participants, so results may not apply to everyone. The shorter schedule might not control the cancer as well as standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

37 people

The number who actually took part.

Started

Jul 2019

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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 * 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. Exclusion Criteria * 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

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma HNSCC

Contacts and locations

Locations

  • Mount Sinai Chelsea

    New York, New York, 10011, United States

  • Mount Sinai Downtown Union Square

    New York, New York, 10003, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Mount Sinai West

    New York, New York, 10019, United States

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