This phase I trial studies the side effects and best dose of stereotactic or hypofractionated radiation therapy in treating patients with head and neck cancer that has returned after a period of improvement or has spread to other places in the body. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated intensity-modulated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving stereotactic and hypofractionated radiation therapy may work better in treating patients with head and neck cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02474368.
PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of stereotactic or hypofractionated treatments in the head and neck.
SECONDARY OBJECTIVES:
I. To determine the 1-year local control rate.
II. To determine the 1-year regional control rate.
III. To determine the 1-year progression free survival (cohort 1).
IV. To investigate immune responses engendered by stereotactic treatment.
V. Determination of the maximum tolerated dose (MTD) and dose-limiting toxicities of stereotactic treatment or hypofractionated boost for: 1) patients who have received prior radiation in the head and neck and currently have gross unresectable disease or microscopic positive margins; 2) patients amenable to palliative treatment with targetable lesions within the head and neck.
VI. To investigate changes in patient reported quality of life after treatment using the validated University of Washington Quality of Life Questionnaire version 4 (UW-QOL v4), administered at baseline, and 1, 2, 3, 6, 9 and 12 months following radiation.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment cohorts.
COHORT I: Patients receive cisplatin intravenously (IV) over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo intensity-modulated radiation therapy (IMRT) 5 days a week (Monday-Friday) for 6 weeks. After 6 weeks, patients undergo hypofractionated IMRT once weekly for 2 weeks in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients undergo stereotactic body radiation therapy 5 treatments over 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 week, 4 weeks, 2 and 3 months, and then every 3 months for 3 years from study enrollment.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJonathan Daniel Schoenfeld
