A Phase I Study of Intensity Modulated Radiotherapy (IMRT) for Malignant Pleural Mesothelioma After Radical Pleurectomy/Decortication (PD)
IMRT is a technique to deliver radiation that allows the radiation beam to be shaped around
the target area.
Radiation Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to receive
one of two doses of radiation therapy based on when you joined the study. If the first dose
is tolerated well by the first group of participants in this study, then the next group of
participants will receive the second, higher dose of radiation.
You will have a practice radiation visit about 6-14 weeks after your surgery. At this visit,
you will have a computed tomography (CT) scan that will be used by the study staff to target
where you will receive the IMRT.
A mold will also be made around your body and marks will be made on your skin to help
position your body correctly for the IMRT. This practice visit should take about 1-2 hours.
Two (2) weeks after the practice radiation visit, you will begin receiving IMRT. At each
visit, you will lie down in the mold of your body that was made at the practice visit and
you will be lined up for the IMRT using the marks made at the practice visit. The IMRT will
then be delivered. You will receive IMRT every weekday (Monday-Friday) for up to 5 weeks.
These visits should last about 45-60 minutes.
The following tests and procedures will be performed 1 time every week for up to 5 weeks
while you are on study:
- You will have a physical and skin exam.
- You will have lung function tests.
You will also have a chest x-ray and a four-dimensional (4D) CT scan to check the status of
the disease during the last week that you are receiving IMRT. A 4D CT scan is performed
just like a CT scan, but during the 4D CT scan, a small black box (about the size of a deck
of cards) will be placed on your abdomen. This box will allow more views of the tumor to be
seen during the scan by the study staff.
Length of Study:
You may receive IMRT for up to 5 weeks. The IMRT will be stopped early if the disease gets
worse or intolerable side effects occur.
One (1) month after your last dose of IMRT, you will have a chest x-ray, lung function
tests, 4D CT scan and a physical exam. The chest x-ray and CT scan will be performed to
check the status of the disease.
Two (2) months after your last dose of IMRT, you will have a chest x-ray and a physical
Three (3) months after your last dose of IMRT, you will have a chest x-ray, lung function
tests, a physical exam, a 4D CT scan and a regular CT scan of your chest. The chest x-ray
and CT scans will be performed to check the status of the disease.
Every 3 months for 2 years, every 6 months for the next 3 years, and 1 time every year after
that, you will have lung function tests, a physical exam, and alternating CT and positron
emission tomography (PET) scans to check the status of the disease. This means that if you
have a CT scan at one visit, you will have a PET scan at the next visit, or vice versa.
This is an investigational study. IMRT given directly to the pleura in patients with MM
after a pleurectomy is currently being used for research purposes only.
Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD)
MTD by assessing the toxicity of two different whole-pleura radiation doses.
Daniel Gomez, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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