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Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 1NCT04870840

Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer

A Phase 1 study testing Proton Beam Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Locally Advanced Head and Neck Squamous Cell Carcinoma and Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Proton Beam Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
19 Oct 2020to 11 Jul 2023
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven diagnosis of squamous cell carcinoma of head and neck cancer originating in the oropharynx, hypopharynx, larynx, oral cavity (base of tongue) or nasopharynx. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the image tumor characteristic of the primary tumor
  • Negative for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (ISH)
  • Inoperable locally advances disease, i.e. stage >= III and T stage >= 2
  • The primary radiotherapy, either in combination with chemotherapy or not, with curative intent
  • No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
  • Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
  • For females of child-bearing age, a negative pregnancy test

Who cannot join

  • Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their head and neck squamous cell carcinoma (HNSCC)
  • Patient that refuse or are unable to stop smoking and/or consuming alcohol during and after radiotherapy. In addition, patients that refuse or fail tobacco and alcohol blood test
  • Patients that have no detectable no tumor in both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost
  • Patients unable or unwilling to give written, informed consent or to undergo magnetic resonance imaging (MRI) imaging
  • Women of childbearing potential (a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]). Male partners must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
  • Patients unable to tolerate intravenous contrast for both computed tomography (CT) and MRI, having an estimated glomerular filtration rate (GFR) < 60 ml/min/1.73 m^2 or any contraindications to gadolinium-based contrast agents
  • Contraindications to iron supplementation include hemochromatosis, colitis, history of gastrointestinal (GI) bleeds, alcoholism, or liver disease. Ferumoxytol is contraindicated in patients with evidence of iron overload and/or known hypersensitivity to Feraheme or any of its components. Consequently, we will plan to exclude patients who have symptoms or signs that might be caused by iron overload. These include patients with (unexplained): arthritis (including premature osteoarthritis), congestive heart failure or cardiomyopathy, adult-onset diabetes, secondary hypogonadism, increased skin pigmentation, or patients with persistently elevated serum ferritin not explained by an underlying inflammatory/systemic disease, unless these patients demonstrate a fasting transferrin saturation =< 0.45
  • Patients with any evidence of iron overload on pre-imaging laboratory studies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]

This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the safety \& feasibility of image guided mid-treatment hyper-fractioned dose-escalation with proton therapy and identify the maximum tolerable dose (MTD) for the treatment of locally advanced human papillomavirus (HPV) negative head and neck cancer.

OUTLINE:

Patients undergo radiation therapy once daily (QD) 5 days a week (Monday through Friday) for the first 18 days and then twice daily (BID) for 15 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 8 weeks, 3, 6, 9, and 12 months in the first year after radiation therapy, every 4 months in the second year after radiation therapy, and then every 9 months thereafter.

Being tested
Proton Beam Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Nasopharyngeal Carcinoma, Carcinoma

What participants receive

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

  • Proton Beam Radiation TherapyRadiation

    Also called PBRT, Proton Radiation Therapy, Radiation, Proton Beam

    Undergo radiation therapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04870840
Study groupRoleWhat they receive
Treatment (proton therapy)ExperimentalPatients undergo radiation therapy QD 5 days a week (Monday through Friday) for the first 18 days and then BID for 15 days in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

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

  1. Incidence of severe unacceptable local adverse events which are radio therapeutically attributable

    Specifically, Common Terminology Criteria for Adverse Events (CTCAE) version 5 grade 4 mucositis, dermatitis or aspiration that does not resolve to a grade =< 3 in 3 months, and CTCAE version 5 grade >= 3 myelopathy, and/or osteonecrosis. Summary statistics, including mean, standard deviation and 95% confidence interval will be used to describe safety data. Toxicity will be tabulated and summarized by grade and type.

    Measured: Up to 6 months after radiation therapy

Secondary outcomes (1)

  1. Incidence of grade 3 toxicity

    Specifically, CTCAE version 5 grade 3 mucositis, dermatitis, aspiration, dysphagia, hearing impaired, xerostomia, weight loss, trismus, hoarseness, oropharyngeal pain. Summary statistics, including mean, standard deviation and 95% confidence interval will be used to describe safety data. Toxicity will be tabulated and summarized by grade and type. Radiation induced side effect (RISE) rate will be summarized by frequency, standard deviation and 95% confidence interval.

    Measured: At 3-6 months after radiation therapy

Timeline

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

  1. First posted4 May 2021
  2. Study start19 Oct 2020
  3. Primary completion11 Jul 2023
  4. Study completion11 Jul 2023

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04870840
Sponsor's protocol ID
2019-0467
Other IDs
NCI-2020-04072, 2019-0467
Status last verified
Jul 2023
First submitted
23 Jun 2020
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • van Dijk LV, Frank SJ, Yuan Y, Gunn B, Moreno AC, Mohamed ASR, Preston KE, Qing Y, Spiotto MT, Morrison WH, Lee A, Phan J, Garden AS, Rosenthal DI, Langendijk JA, Fuller CD. Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial of MRI-guided adaptive particle radiotherapy. Clin Transl Radiat Oncol. 2021 Nov 11;32:35-40. doi: 10.1016/j.ctro.2021.11.003. eCollection 2022 Jan.

    PubMed 34841093

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Proton Beam Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Locally Advanced Head and Neck Squamous Cell Carcinoma and Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, run by M.D. Anderson Cancer 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 7 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 29 Oct 2024. 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?

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?

Incidence of severe unacceptable local adverse events which are radio therapeutically attributable (time frame: Up to 6 months after radiation therapy). 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 NCT04870840, which also lists 1 linked publication.

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 29 Oct 2024.

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