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

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Photon intensity modulated radiation therapy (IMRT)
Proton beam radiotherapy (PBRT)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring proton-beam radiation therapy (PBRT), intensity-modulated radiation therapy (IMRT), 16-1416

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Alliance MCIRecruiting
  • Mayo ClinicRecruiting
  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • Memorial Sloan Kettering CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Mount Sinai Hospital
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Photon intensity modulated radiation therapy (IMRT)

Proton beam radiotherapy (PBRT)

Arm Description

IMRT to standard dose of 60-66Gy

PBRT to standard dose of 60-66Gy

Outcomes

Primary Outcome Measures

number of patients with grade 2 or greater acute mucositis
via the CTCAE v4.0.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2016
Last Updated
November 2, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Mayo Clinic, Mount Sinai Hospital, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02923570
Brief Title
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Official Title
A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Mayo Clinic, Mount Sinai Hospital, New York

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
proton-beam radiation therapy (PBRT), intensity-modulated radiation therapy (IMRT), 16-1416

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photon intensity modulated radiation therapy (IMRT)
Arm Type
Experimental
Arm Description
IMRT to standard dose of 60-66Gy
Arm Title
Proton beam radiotherapy (PBRT)
Arm Type
Experimental
Arm Description
PBRT to standard dose of 60-66Gy
Intervention Type
Radiation
Intervention Name(s)
Photon intensity modulated radiation therapy (IMRT)
Intervention Description
Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.
Intervention Type
Radiation
Intervention Name(s)
Proton beam radiotherapy (PBRT)
Intervention Description
Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.
Primary Outcome Measure Information:
Title
number of patients with grade 2 or greater acute mucositis
Description
via the CTCAE v4.0.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Lee, MD
Phone
212-639-3341
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Barker, MD
Phone
212-639-8168
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Alliance MCI
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Kalman, MD
Phone
786-596-2000
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Foote, MD
Phone
507-284-2511
First Name & Middle Initial & Last Name & Degree
Robert Foote, MD
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Bakst, MD
Phone
212-241-3545
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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