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Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma

Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Squamous Cell Carcinoma of the Oropharynx

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Trial Information

Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma

After confirming that you are eligible for this study and your willingness to participate in
it, we will perform a radiation treatment stimulation, or "mapping session," within the next
two weeks. You may or may not receive intravenous contrast during the process, which allows
your physician to better see the blood vessels in your neck. You will be placed in a mask
during this process to help keep you in the same place during each treatment. All of this is
part of standard radiation treatment.

Approximately 14 days later, you will start radiation treatment to your primary tumor site
and to your lymph nodes and chemotherapy in the same week. The chemotherapy will continue to
be given one time per week during each week of treatment. You will receive radiation
treatment 5 days a week for seven weeks. One day each during the first and second weeks of
treatment, instead of the typical radiation dose, you will receive a dose of the
stereotactic radiation boost to the site of the primary tumor (total of 2 doses of
stereotactic radiotherapy).

Because we are looking for the highest dose of the stereotactic radiation boost that can be
administered safely without severe or unmanageable side effects, not everyone who
participates in this research study will receive the same dose of the stereotactic radiation
boost. The dose you get will depend on the number of participants who have been enrolled in
the study before you and how well they have tolerated their doses. We are testing 3
different dose levels for the stereotactic radiation boost; your dose will be one of those 3

The chemotherapy will be given one time per week, each week, for the duration of the
radiation treatment (7 weeks). The chemotherapy is delivered through intravenous fluids that
run through a vein in your arm. This is the same chemotherapy that you would receive if you
were not participating in the study.

You will be seen by your radiation oncologist at least once every week during treatment.

After the final dose of radiation treatment all subsequent follow-up visits and tests are
performed in accordance with standard cancer care. You will see your radiation oncologist,
with or without the medical oncologist, at the following time intervals: 1 week after
treatment ends, 1 month after treatment ends, 2 months after treatment ends, and then every
3 months for two years. You will undergo a PET-CT scan and neck CT scan at the time of the 3
month appointment.

You will be on the study treatment for about 7 weeks and your progress will be followed as
part of the study for 2 years after treatment ends.

Inclusion Criteria:

- Previously untreated histologically or cytologically confirmed T2-4, N0-3
HPV16-negative oropharyngeal squamous cell carcinoma or HPV16 positivity with at
least a 10 pack-year smoking habit

- Measurable disease

- Life expectancy of greater than 6 months

Exclusion Criteria:

- Other active malignancy within the past 5 years (except for non-melanoma skin cancer
or carcinoma in situ of the cervix)

- Primary tumor size > 6 cm

- Prior history of head and neck radiotherapy

- Receiving any other study agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to cisplatin

- Uncontrolled intercurrent illness

- Pregnant or breastfeeding

- HIV positive on combination antiretroviral therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of MTD

Outcome Description:

Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for poor-prognosis oropharyngeal squamous cell carcinoma

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

June 2013

Related Keywords:

  • Squamous Cell Carcinoma of the Oropharynx
  • poor prognosis
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Oropharyngeal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115