Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma



Status:Withdrawn
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:November 2011
End Date:September 2015

Use our guide to learn which trials are right for you!

Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of
an investigational intervention (in this case, the stereotactic radiation boost). Phase I
studies also try to define the appropriate dose of the investigational intervention to use
for further studies. "Investigational" means that the stereotactic radiation treatment is
still being studied and that research doctors are trying to find out more about it. It also
means that the FDA has not approved a stereotactic radiation boost for your type of cancer.

In this research study, the investigators are looking for the highest dose of the
stereotactic radiation boost that can be given safely. Because the stereotactic radiation
boost 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 you experience;
the goal is to improve the likelihood of successfully treating the tumor.

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
doses.

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
We found this trial at
2
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials