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Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923570
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : November 4, 2022
Sponsor:
Collaborators:
Mayo Clinic
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Photon intensity modulated radiation therapy (IMRT) Radiation: Proton beam radiotherapy (PBRT) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a phase II randomized two-arm trial comparing proton-beam radiation therapy (PBRT) with photon- based intensity-modulated radiation therapy (IMRT) for cancers in the head and neck region requiring ipsilateral radiation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
Actual Study Start Date : October 3, 2016
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Photon intensity modulated radiation therapy (IMRT)
IMRT to standard dose of 60-66Gy
 Radiation: Photon intensity modulated radiation therapy (IMRT)
Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.
Experimental: Proton beam radiotherapy (PBRT)
PBRT to standard dose of 60-66Gy
 Radiation: Proton beam radiotherapy (PBRT)
Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.


Outcome Measures
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Primary Outcome Measures :
  1. number of patients with grade 2 or greater acute mucositis [ Time Frame: 1 year ]
    via the CTCAE v4.0.


Eligibility Criteria
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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:

  • Age greater than or equal to 18.

  • Histopathologically confirmed diagnosis of one the following cancer types:

    • Salivary gland cancer
    • Skin cancer
    • Melanoma
  • HNSCC that require ipsilateral radiation
  • Patients must be a candidate for ipsilateral radiation therapy.
  • Karnofsky performance status ≥70.
  • Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy.

Exclusion Criteria:

  • Any prior head or neck irradiation.
  • Physician recommendation of bilateral neck radiation.
  • Non-resectable disease
  • Physician recommendation of mucosal radiation
Contacts and Locations
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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): NCT02923570


Contacts
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Contact: Nancy Lee, MD 212-639-3341
Contact: Christopher Barker, MD 212-639-8168

Locations
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United States, Florida
Baptist Alliance MCI Recruiting
Miami, Florida, United States, 33143
Contact: Noah Kalman, MD    786-596-2000      
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert Foote, MD    507-284-2511      
Principal Investigator: Robert Foote, MD         
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Nancy Lee, MD    212-639-3341      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Nancy Lee, MD    212-639-3341      
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Richard Bakst, MD    212-241-3545      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy Lee, MD    212-639-3341      
Contact: Christopher Barker, MD    212-639-8168      
Principal Investigator: Nancy Lee, MD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Nancy Lee, MD    212-639-3341      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Mayo Clinic
Mount Sinai Hospital, New York
Investigators
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Principal Investigator: Nancy Lee, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02923570    
Other Study ID Numbers: 16-1416
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
proton-beam radiation therapy (PBRT)
intensity-modulated radiation therapy (IMRT)
16-1416
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms