Clinical Trials /

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

NCT04870840

Description:

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).

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Nasopharyngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer
  • Official Title: Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]

Clinical Trial IDs

  • ORG STUDY ID: 2019-0467
  • SECONDARY ID: NCI-2020-04072
  • SECONDARY ID: 2019-0467
  • NCT ID: NCT04870840

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
  • Locally Advanced Laryngeal Squamous Cell Carcinoma
  • Locally Advanced Nasopharyngeal Squamous Cell Carcinoma
  • Locally Advanced Oral Cavity Squamous Cell Carcinoma
  • Locally Advanced Oropharyngeal Squamous Cell Carcinoma
  • Malignant Posterior Tongue Neoplasm
  • Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage II Hypopharyngeal Carcinoma AJCC v8
  • Stage II Laryngeal Cancer AJCC v8
  • Stage II Nasopharyngeal Carcinoma AJCC v8
  • Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage III Hypopharyngeal Carcinoma AJCC v8
  • Stage III Laryngeal Cancer AJCC v8
  • Stage III Nasopharyngeal Carcinoma AJCC v8
  • Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Unresectable Head and Neck Squamous Cell Carcinoma
  • Unresectable Oropharyngeal Squamous Cell Carcinoma

Purpose

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).

Detailed Description

      PRIMARY OBJECTIVE:

      I. 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.
    

Trial Arms

NameTypeDescriptionInterventions
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.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  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
    
            Exclusion Criteria:
    
              -  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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence of severe unacceptable local adverse events which are radio therapeutically attributable
    Time Frame:Up to 6 months after radiation therapy
    Safety Issue:
    Description: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.

    Secondary Outcome Measures

    Measure:Incidence of grade 3 toxicity
    Time Frame:At 3-6 months after radiation therapy
    Safety Issue:
    Description: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.

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Last Updated

    May 4, 2021