Proton Beam or Photon-Based Intensity-Modulated Radiation Therapy in Treating Patients with Salivary Gland Cancer, Skin Cancer, or Melanoma
- 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
- Any prior head or neck irradiation
- Physician recommendation of bilateral neck radiation
- Non-resectable disease
- Physician recommendation of mucosal radiation
- Use of chemotherapy
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.
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 Phase II
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Nancy Y. Lee
- Primary ID 16-1416
- Secondary IDs NCI-2016-01575
- Clinicaltrials.gov ID NCT02923570