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Head and Neck CancerPhase 1NCT05540899

Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer

A Phase 1 study testing Hypofractionated Postoperative Radiotherapy in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by American College of Radiology at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Hypofractionated Postoperative Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
8 Nov 2023to Nov 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post- radiation complications.
  • Clinical stage I-IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
  • General history and physical examination prior to registration;
  • Chest X-ray (at a minimum) or chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) prior to registration.
  • Total resection of the patient's cancer (i.e. no residual disease after total resection of the patient's cancer).
  • One or more indications for postoperative radiotherapy, based upon pathologic findings:
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  • Perineural invasion;
  • Lymphovascular invasion;
  • Single lymph node ≥ 3 cm or ≥ 2 lymph nodes (no extracapsular Extension);
  • Close margin(s) of resection (close margins defined as cancer extending to within 5 mm of a surgical margin);
  • Pathologically confirmed T3 or T4a primary tumor;
  • T2 oral cavity cancer with ≥ 5 mm depth of invasion.
  • Zubrod Performance Status 0-1.
  • Age 18-80.
  • Negative pregnancy test within 14 days prior to registration for participants who may become pregnant.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety assessment of the investigational regimen are eligible for this trial.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

Who cannot join

  • Recurrence of the study cancer.
  • History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
  • Pregnancy and individuals unwilling to discontinue nursing.
  • Reliant on a feeding tube (gastric or jejuno) to maintain adequate nutrition at the time of registration
  • Anticipated need for high-dose systemic chemotherapy (e.g., high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; prior chemotherapy for study cancer is not allowed.
  • Per the operative and/or pathology report, positive margin(s) [defined as tumor present at the cut or inked edge of the tumor], nodal extracapsular extension, and/or gross residual disease after surgery; Note: Patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Phase I Safety Assessment of Hypofractionated Postoperative Radiotherapy (H-PORT) for Intermediate-Risk Head and Neck Cancer

This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if a hypofractionated postoperative radiotherapy (H-PORT) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase II clinical trial.

SECONDARY OBJECTIVES:

  1. To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion.

II. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications.

ARM I: Patients undergo surgery per standard of care followed by hypofractionated radiotherapy. Patients receive 50 Gy over 4 weeks (i.e., 2.5 Gy per day x 20 fractions). Radiation therapy should start after there is adequate healing and no evidence of gross residual/recurrent cancer.

Patients are followed up at 1 month, 3 months, 6 months and 12 months post H-PORT therapy.

Being tested
Hypofractionated Postoperative Radiotherapy
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated Postoperative RadiotherapyRadiation

    Also called H-PORT

    Hypofractionated Postoperative Radiation Therapy

Study groups in NCT05540899
Study groupRoleWhat they receive
Hypofractionated Postoperative Radiotherapy (H-PORT)ExperimentalH-PORT of 50 Gy given over 4 weeks.
Receives: Radiation: Hypofractionated Postoperative Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT)

    All grades are based on Common Terminology Criteria for Adverse Events (CTCAE v.5). H-PORT in this population will be deemed safe if 0-2 patients out of the first 12 evaluable patients experience DLTs. Should 3 or more patients experience DLTs at any time point during the DLT evaluation period, then accrual to the trial will be stopped, if applicable.

    Once 12 evaluable eligible patients have completed their DLT assessment, the rate of unacceptable DLTs and 95% confidence interval will be summarized using proportions for binary outcomes and the exact binomial method.

    Measured: From the start of H-PORT up 12 months post-radiation

Secondary outcomes (3)

  1. Incidence of Adverse Events

    Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Counts and percentages will be provided for the worst grade AE experienced.

    Measured: From the start of H-PORT up to 12 months post-radiation

  2. Rate of radiation interruptions

    Counts and percentages will be provided for treatment interruptions.

    Measured: From the start to the end of H-PORT, assessed up to 4 weeks

  3. Rate of radiation discontinuations

    Counts and percentages will be provided for treatment discontinuations.

    Measured: From the start to the end of H-PORT, assessed up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2022
  2. Study start8 Nov 2023
  3. Primary completionJul 2027 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05540899
Sponsor's protocol ID
ACR 3518
Status last verified
Jul 2025
First submitted
9 Sep 2022
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hypofractionated Postoperative Radiotherapy in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by American College of Radiology at 1 site 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 17 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Dose-Limiting Toxicity (DLT) (time frame: From the start of H-PORT up 12 months post-radiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05540899.

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 24 Jul 2025.

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Clinical Trial NCT05540899 | AzTrials