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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 : December 31, 2020
Sponsor:
Collaborators:
Mayo Clinic
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE October 3, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date December 31, 2020
Actual Study Start Date  ICMJE October 3, 2016
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
number of patients with grade 2 or greater acute mucositis [ Time Frame: 1 year ]
via the CTCAE v4.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Official Title  ICMJE A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Radiation: Photon intensity modulated radiation therapy (IMRT)
  • Radiation: Proton beam radiotherapy (PBRT)
Study Arms  ICMJE
  • Experimental: Photon intensity modulated radiation therapy (IMRT)
    IMRT to standard dose of 60-66Gy
    Intervention: Radiation: Photon intensity modulated radiation therapy (IMRT)
  • Experimental: Proton beam radiotherapy (PBRT)
    PBRT to standard dose of 60-66Gy
    Intervention: Radiation: Proton beam radiotherapy (PBRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than or equal to 18.
  • Histopathologically confirmed diagnosis of one the following cancer types:

    • Salivary gland cancer without the presence of extracapsular extension and/or positive surgical margin.
    • Skin cancer
    • Melanoma
  • 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
  • Use of chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nancy Lee, MD 212-639-3341
Contact: Oren Cahlon, MD 212-639-5219
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02923570
Other Study ID Numbers  ICMJE 16-1416
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Mayo Clinic
  • Mount Sinai Hospital, New York
Investigators  ICMJE
Principal Investigator: Nancy Lee, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP