This 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, melanoma, or head and neck squamous cell cancer. 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, melanoma, or head and neck squamous cell cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02923570.
PRIMARY OBJECTIVE:
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, skin cancer, melanoma, or head and neck squamous cell carcinoma (HNSCC) 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.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNancy Y. Lee
