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NCT Number: NCT02923570

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baptist Alliance MCI, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. number of patients with grade 2 or greater acute mucositis

    Time frame: 1 year

    via the CTCAE v4.0.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Mayo Clinic

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2016
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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