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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Head and Neck Cancer

Treatments: Radiation: Photon intensity modulated radiation therapy (IMRT); Radiation: Proton beam radiotherapy (PBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02923570

16-1416

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Photon intensity modulated radiation therapy (IMRT)

Experimental group

Description:

IMRT to standard dose of 60-66Gy

Treatment:

Radiation: Photon intensity modulated radiation therapy (IMRT)

Proton beam radiotherapy (PBRT)

Experimental group

Description:

PBRT to standard dose of 60-66Gy

Treatment:

Radiation: Proton beam radiotherapy (PBRT)