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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Photon intensity modulated radiation therapy (IMRT)

IMRT to standard dose of 60-66Gy

Group Type EXPERIMENTAL

Photon intensity modulated radiation therapy (IMRT)

Intervention Type RADIATION

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

Proton beam radiotherapy (PBRT)

PBRT to standard dose of 60-66Gy

Group Type EXPERIMENTAL

Proton beam radiotherapy (PBRT)

Intervention Type RADIATION

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

Interventions

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Photon intensity modulated radiation therapy (IMRT)

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

Intervention Type RADIATION

Proton beam radiotherapy (PBRT)

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No