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

A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02923570

Enrollment

108

Registered

2016-10-04

Start date

2016-10-03

Completion date

2026-10-31

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

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

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.

Interventions

RADIATIONPhoton intensity modulated radiation therapy (IMRT)

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

RADIATIONProton beam radiotherapy (PBRT)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
number of patients with grade 2 or greater acute mucositis	1 year	via the CTCAE v4.0.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026