A Phase 1 interventional study of IMRT in Lung Cancer and Mesothelioma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given to directly to the pleura (the outer lining of the lungs) using intensity modulated radiation therapy (IMRT) in patients with MM who have had a pleurectomy.
IMRT:
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.
Practice Visit:
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.
IMRT Visits:
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.
Study Visits:
The following tests and procedures will be performed 1 time every week for up to 5 weeks while you are on study:
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.
Follow-up Visits:
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 exam.
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.
Long-term Follow-up:
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.
470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 371 interventional studies indexed under Mesothelioma.
Browse Mesothelioma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intensity Modulated Radiation Therapy (IMRT) Delivery of whole-pleura radiation doses beginning with 1) 45 Gy to low-risk region and 60-66 Gy to high-risk region; then 2) the same dosing regimen as above with a third dosing level, 50 Gy to an intermediate-dosing region. Every weekday (Monday-Friday) for up to 5 weeks, lasting about 45-60 minutes.
Radiation: IMRT
Delivery of whole-pleura radiation doses beginning with 1) 45 Gy to low-risk region and 60-66 Gy to high-risk region; then 2) the same dosing regimen as above with a third dosing level, 50 Gy to an intermediate-dosing region. Every weekday (Monday-Friday) for up to 5 weeks, lasting about 45-60 minutes.
Also known as: Intensity modulated radiation therapy
Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD)
MTD by assessing the toxicity of two different whole-pleura radiation doses.
Time frame: 3 Months
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center