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Squamous Cell Carcinoma of Head and NeckPhase 1/2NCT04403620

HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer

A Phase 1/2 study testing Intensity-modulated Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of Head and Neck, run by University of Texas Southwestern Medical Center 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

There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Intensity-modulated Radiation Therapy (IMRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
28 Jul 2020to Aug 2027
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria will be the same for Phase I and Phase II.
  • Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx status post gross total resection with pathology showing one or more of the following intermediate risk factors:
  • T3/4 disease (AJCC 8th edition), positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion
  • Close margin(s) defined as either:
  • Final patient margin of <5 mm without disease on ink OR
  • Initial positive margin in the specimen regardless of the final patient margin (e.g. if resection margin on the initial specimen is positive, final patient margin after subsequent resections can be ≥5 mm and still be considered close margin)
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  • Age ≥18 years
  • ECOG performance status 0-2
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
  • Medically acceptable birth control (contraceptives) includes:
  • approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or
  • barrier methods (such as condom or diaphragm) used with a spermicide
  • Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
  • Ability to understand and the willingness to sign a written informed consent

Who cannot join

  • Phase I:
  • Distant metastasis
  • Stage I and II glottic squamous cell carcinoma
  • High risk factors following surgical resection requiring concurrent chemotherapy: final positive margin(s) and/or extranodal extension
  • Feeding tube dependence at baseline assessment.
  • Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer. For prostate cancer, patient should not be receiving active treatment. For thyroid cancer, thyroid surgery may occur before or after treatment, provided all other eligibility criteria are met.
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  • Prior invasive malignancy with an expected disease-free interval of less than 3 years
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
  • Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant
  • Phase II:
  • The exclusion criteria will be the same as Phase I except for feeding tube dependence. Patients who are feeding tube dependent are excluded from Phase I to accurately assess treatment associated toxicity affecting swallowing and oral intake. During Phase II, patients who are feeding tube dependent will be eligible to enroll and stratified at randomization.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

Other trials in United States

About this study

Official title: HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma

There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting.

Read the detailed description

The trial will assess the effects of aggressive hypofractionated radiation therapy in patients with oral cavity, oropharynx, hypopharynx, or larynx cancer after surgical resection with pathology showing intermediate risk factors requiring post-operative radiation therapy without concurrent chemotherapy. During Phase 1, the maximum tolerated dose/fractionation and tolerability will be determined. During Phase 2, patients will be randomized between conventionally fractionated radiation therapy (6 weeks) vs. hypofractionated radiation therapy (3 weeks) to establish non-inferiority of hypofractionated radiation therapy.

Being tested
Intensity-modulated Radiation Therapy (IMRT)
Keywords
Radiation Dose Hypofractionation, Adjuvant Radiotherapy
Medical subject headings
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.

  • Intensity-modulated Radiation Therapy (IMRT)Radiation

    Patients will receive adjuvant radiation therapy using intensity-modulated radiation therapy (IMRT) within 8 weeks of surgical resection

Study groups in NCT04403620
Study groupRoleWhat they receive
Conventionally fractionated radiotherapyActive comparator60 Gy in 30 fractions, 5 fractions/week
Receives: Radiation: Intensity-modulated Radiation Therapy (IMRT)
Hypofractionated radiotherapyExperimentalDose and fractionation determined by Phase I: Level 1: 44.4 Gy in 12 fractions, 4 fractions/week Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week Level -2: 50 Gy in 20 fractions, 5 fractions/week
Receives: Radiation: Intensity-modulated Radiation Therapy (IMRT)

What is being measured

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

  1. Phase 1: Maximally tolerated dose of hypofractionated radiation therapy

    Dose and fractionation to be used for Phase 2

    Measured: 3 months

  2. Phase 2: Swallowing-related patient-reported quality of life

    MD Anderson Dysphagia Inventory (MDADI) composite score: 20-100, higher scores mean better quality of life

    Measured: 12 months

Secondary outcomes (9)

  1. Clinician-reported acute toxicities

    CTCAE v5.0

    Measured: 1-3 months

  2. Clinician-reported late toxicities

    CTCAE v5.0

    Measured: 6-24 months

  3. Locoregional control

    Measured: 12-24 months

  4. Progression free survival

    Measured: 12-24 months

  5. Swallowing-related patient-reported quality of life

    MD Anderson Dysphagia Inventory (MDADI): 20-100, higher scores mean better quality of life

    Measured: 1-24 months

  6. Head and neck patient-reported quality of life

    University of Washington QOL questionnaire (UW-QOL): 0-100, higher scores mean better quality of life

    Measured: 1-24 months

  7. Xerostomia-related patient-reported quality of life

    University of Michigan Xerostomia questionnaire (XQ): 0-100, higher scores mean worse quality of life

    Measured: 1-24 months

  8. General patient-reported quality of life

    EuroQol-5 dimensions (EQ-5D-5L): 1-5, higher scores mean worse quality of life

    Measured: 1-24 months

  9. Feeding tube dependence

    Feeding tube dependence defined as daily use of the feeding tube with ≥2 nutritional supplements (e.g. Ensure, Boost, etc.) per day at the time of enrollment on trial

    Measured: 1-24 months

Timeline

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

  1. First posted27 May 2020
  2. Study start28 Jul 2020
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Dose/fractionation finding Phase 1 study, followed by a randomized Phase 2 study
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04403620
Sponsor's protocol ID
STU-2020-0522
Status last verified
Apr 2026
First submitted
14 May 2020
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intensity-modulated Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of Head and Neck, run by University of Texas Southwestern Medical Center 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 18 inclusion and 14 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 6 May 2026. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Phase 1: Maximally tolerated dose of hypofractionated radiation therapy (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04403620.

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 6 May 2026.

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