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

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ClinicalTrials.gov Identifier: NCT04870840
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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). 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).

Condition or disease Intervention/treatment Phase
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 Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022


Arm Intervention/treatment
Experimental: Treatment (proton therapy)
Patients 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.
Radiation: Proton Beam Radiation Therapy
Undergo radiation therapy
Other Names:
  • PBRT
  • Proton Radiation Therapy
  • Radiation, Proton Beam

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Incidence of severe unacceptable local adverse events which are radio therapeutically attributable [ Time Frame: Up to 6 months after radiation therapy ]
    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 :
  1. Incidence of grade 3 toxicity [ Time Frame: At 3-6 months after radiation therapy ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870840


Contacts
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Contact: Clifton D Fuller 713-563-2300 cdfuller@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clifton D. Fuller    713-563-2300      
Principal Investigator: Clifton D. Fuller         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Clifton D Fuller M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04870840    
Other Study ID Numbers: 2019-0467
NCI-2020-04072 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0467 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Nasopharyngeal Carcinoma
Squamous Cell Carcinoma of Head and Neck
Laryngeal Neoplasms
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Mouth Neoplasms
Mouth Diseases
Tongue Diseases