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NCT02923570 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02923570
Other study ID # 16-1416
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 3, 2016
Est. completion date October 2025

Study information
Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact Nancy Lee, MD
Phone 212-639-3341
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 108
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Photon intensity modulated radiation therapy (IMRT)
Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.
• Proton beam radiotherapy (PBRT)
Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Baptist Alliance MCI Miami Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mayo Clinic Rochester Minnesota
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Mayo Clinic

Country where clinical trial is conducted

United States, 

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