A Phase 1 interventional study of Intensity Modulated Radiation Therapy (IMRT) and Cisplatin in Recurrent Head and Neck Carcinoma, Head and Neck Cancer Metastatic and Head or Neck Cancer, sponsored by Dana-Farber Cancer Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 21 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must have normal organ and marrow function as defined below:
Cohort 2 (patients with metastatic disease with targetable lesions within the head and neck):
Exclusion Criteria:
Patients who are planned to receive the following medications:
* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 1 (patients who have received prior radiation in the head and neck with gross unresectable disease) * Intensity Modulated Radiation Therapy (IMRT) : daily for 6 weeks * Cisplatin will be administered intravenously on predetermined days * Stereotactic Body Radiotherapy (SBRT)
Radiation: Intensity Modulated Radiation Therapy (IMRT) · Drug: Cisplatin · Radiation: Stereotactic Body Radiotherapy (SBRT)
* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 2 (patients with metastatic solid tumors of any histology who have targetable lesions within the head and neck) -- Stereotactic Body Radiotherapy (SBRT)
Radiation: Stereotactic Body Radiotherapy (SBRT)
Also known as: Platinol-AQ, Platinol
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
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute