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

Phase 2Active Not RecruitingNCT02923570

Memorial Sloan Kettering Cancer Center108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Head and Neck Cancer

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.

Proton beam radiotherapy (PBRT)RADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Baptist Alliance MCI

Miami, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Outcomes

Primary Outcomes

number of patients with grade 2 or greater acute mucositis

via the CTCAE v4.0.

Time frame: 1 year

Data from ClinicalTrials.gov

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