Clinical trial NCT02923570: Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Official title: A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: proton-beam radiation therapy (PBRT)
intensity-modulated radiation therapy (IMRT)
16-1416
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2016-10-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of patients with grade 2 or greater acute mucositis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Alliance MCI
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: