Proton Beam or Photon-Based Intensity-Modulated Radiation Therapy in Treating Patients with Salivary Gland Cancer, Skin Cancer, or Melanoma

Status: Active

Description

This randomized phase II trial studies the side effects of proton beam or photon-based intensity-modulated radiation therapy in treating patients with salivary gland cancer, skin cancer, or melanoma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. It is not yet known if proton beam radiation therapy is more effective than photon-based intensity-modulated radiation therapy in treating patients with salivary gland cancer, skin cancer, or melanoma.

Eligibility Criteria

Inclusion Criteria

  • Histopathologically confirmed diagnosis of one of the following cancer types: * Salivary gland cancer without the presence of extracapsular extension and/or positive surgical margin * Skin cancer * Melanoma
  • 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
  • Use of chemotherapy

Locations & Contacts

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Robert L. Foote
Phone: 507-284-2511

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Nancy Y. Lee
Phone: 212-639-3341
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Nancy Y. Lee
Phone: 212-639-3341
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Nancy Y. Lee
Phone: 212-639-3341

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Nancy Y. Lee
Phone: 212-639-3341
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Nancy Y. Lee
Phone: 212-639-3341
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Nancy Y. Lee
Phone: 212-639-3341
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Nancy Y. Lee
Phone: 212-639-3341

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if physician reported acute grade 2 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (v4.03) mucositis is reduced in proton beam radiation therapy (PBRT) compared with intensity-modulated radiation therapy (IMRT) for the treatment of salivary gland cancer without the presence of extracapsular extension and/or positive surgical margin, skin cancer, or melanoma that require post-operative unilateral head and neck irradiation.

SECONDARY OBJECTIVES:

I. To assess the correlation between patient reported outcome (PRO)-CTCAE scores and physician reported CTCAE v4.03 scores in the acute setting.

II. To determine if other acute grade 2 or higher physician rated CTCAE rates are reduced with PBRT compared to IMRT.

III. To determine if acute grade 2 or higher PRO-CTCAE rates are reduced with PBRT compared with IMRT.

IV. To determine if late grade 2 or higher physician reported CTCAE rates are reduced with PBRT compared with IMRT.

V. To determine if late grade 2 or higher PRO-CTCAE rates are reduced with PBRT compared with IMRT.

VI. To determine if there are any differences in 3-year rates of local, regional, or distant-metastasis progression-free interval, progression-free survival, and overall survival between PBRT and IMRT.

VII. To assess the effectiveness of PBRT versus (vs.) IMRT in improving patient-reported body image and function, fatigue and other measures of health-related quality of life (anxiety, social roles, financial toxicity, general, satisfaction) and adverse events.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard-dose photon-based IMRT once daily (QD) over 20 minutes 5 days a week for 6-7 weeks for a total of 30 fractions. Patients may undergo a boost of 3 additional fractions.

ARM II: Patients undergo standard-dose PBRT QD over 20 minutes 5 days a week for 6-7 weeks for a total of 30 fractions. Patients may undergo a boost of 3 additional fractions.

After completion of study treatment, patients are followed up at 2 and 6 weeks, and then at 4, 12, 24, and 36 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Nancy Y. Lee

Trial IDs

Primary ID 16-1416
Secondary IDs NCI-2016-01575
Clinicaltrials.gov ID NCT02923570