NCT02923570

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
4mo left

Started Oct 2016

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Oct 2016Oct 2026

First Submitted

Initial submission to the registry

October 3, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

October 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

10 years

First QC Date

October 3, 2016

Last Update Submit

November 3, 2025

Conditions

Head and Neck Cancer

Keywords

proton-beam radiation therapy (PBRT)intensity-modulated radiation therapy (IMRT)16-1416

Outcome Measures

Primary Outcomes (1)

  • number of patients with grade 2 or greater acute mucositis

    via the CTCAE v4.0.

    1 year

Study Arms (2)

Photon intensity modulated radiation therapy (IMRT)

EXPERIMENTAL

IMRT to standard dose of 60-66Gy

Radiation: Photon intensity modulated radiation therapy (IMRT)

Proton beam radiotherapy (PBRT)

EXPERIMENTAL

PBRT to standard dose of 60-66Gy

Radiation: Proton beam radiotherapy (PBRT)

Interventions

Photon intensity modulated radiation therapy (IMRT)RADIATION

Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.

Photon intensity modulated radiation therapy (IMRT)
Proton beam radiotherapy (PBRT)RADIATION

Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.

Proton beam radiotherapy (PBRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any prior head or neck irradiation.
  • Physician recommendation of bilateral neck radiation.
  • Non-resectable disease
  • Physician recommendation of mucosal radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Baptist Alliance MCI

Miami, Florida, 33143, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Nancy Lee, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 4, 2016

Study Start

October 3, 2016

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations

US(9)