This research study seeks to gain new knowledge about the addition of a carefully targeted "boost" dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. The name of the study intervention involved in this study is stereotactic body radiotherapy, which is a way of delivering radiation in a more precisely targeted way and with a higher dose than conventional radiotherapy.
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. Stereotactic body radiation was developed as imaging and treatment capabilities on radiation treatment machines became more accurate and more precise. Like standard radiation therapy, stereotactic body radiation kills tumor cells by causing small breaks in the DNA of these cells. In this research study, the investigators are looking for the highest dose of the stereotactic radiation that can be given safely either alone, or as a 'boost dose' in combination with standard radiation and chemotherapy. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects; the goal is to improve the likelihood of killing the tumor and, in some cases, to complete the course of radiation in a shorter amount of time.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given as a boost in combination with cisplatin and intensity modulated radiation therapy (IMRT)
Cohort 1: patients who have received prior radiation in the head and neck and currently have gross unresectable disease;
Time frame: 1 Year
Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given for disease metastatic to the head and neck
Cohort 2: Patients with metastatic disease with targetable lesions within the head and neck.
Time frame: 1 year
Number of Participants with Adverse Events
Adverse events observed will be summarized in terms of type (organ affected or laboratory determination), severity (by National Cancer Institute, Common Toxicity Criteria for Adverse Effects - CTCAE v4 and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
Time frame: 1 Year
Local Control Rate
Computed tomography (CT) and Positron emission tomography (PET) will be used to assess disease control within the field receiving radiation.
Time frame: 1 Year
Regional Control Rate
Computed tomography (CT) and Positron emission tomography (PET) will be used to assess disease control within the head and neck region.
Time frame: 1 Year
Progression Free Survival using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Progression free survival will be summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol. The median progression free survival time will be estimated using standard life table methods.
Time frame: 1 year
Level of circulating activated T cells as an immune correlate of stereotactic treatment
This will evaluate circulating immune cells before and after treatment and gene expression analysis focusing on delineating the immune components and immunologic milieu within the tumor before therapy.
Time frame: 1 Year
Patient reported physical function before and after treatment
This will investigate changes in patient reported quality of life after treatment using the validated University of Washington Quality of Life Questionnaire (UW-QOL v4) composite score for physical function and comparing results obtained before and after treatment.
Time frame: 1 year
Patient reported social function before and after treatment
This will investigate changes in patient reported quality of life after treatment using the validated University of Washington Quality of Life Questionnaire (UW-QOL v4) composite score for social function and comparing results obtained before and after treatment.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.