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Targeted Radiation Therapy + Surgery + Chemotherapy for Malignant Pleural Mesothelioma
Study Summary
This trial is testing whether adding targeted radiation therapy to surgery and chemotherapy will work better to treat stage I-IIIA malignant pleural mesothelioma.
- Pleural Malignant Mesothelioma
- Pleural Mesothelioma
- Mesothelioma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2013 Phase 3 trial • 637 Patients • NCT00884741Trial Design
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- You have a large amount of leftover disease in a specific part of your lung that makes it difficult to perform a certain type of radiation treatment called pleural IMRT.You need to use extra oxygen to help you breathe.You have had a surgical procedure called extrapleural pneumonectomy.You have fluid in the space between your lungs and chest wall that cannot be controlled by draining it, or your lung does not expand enough after a specific procedure.You have had a kidney removed on the opposite side of the study.You have received radiation treatment to your chest area in the past, and cannot receive additional radiation treatment in that area due to the risk of harming normal tissues.
- Group 1: Arm I (Step 1: chemotherapy, P/D: Step 2: no treatment)
- Group 2: Arm II (Step 1: chemotherapy, P/D, Step 2: IMRT/PBS)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What does the FDA have to say about Intensity-Modulated Radiation Therapy?
"Intensity-Modulated Radiation Therapy is considered safe, as it has received a score of 3."
How do I sign up for this clinical trial?
"This study is looking for 150 patients with mesothelioma that are malignant and between the ages of 18-80. Candidates must meet the following registration criteria: have a physical examination and history less than 42 days old, an FEV1 score of 40% or higher, imaging proof of clinical stage by PET/CT scan also less than 42 days old."
What are the primary conditions that people usually seek Intensity-Modulated Radiation Therapy treatment for?
"According to the National Cancer Institute, Intensity-Modulated Radiation Therapy can be used as an initial treatment for advanced thymoma and testicular cancer."
Are there any current vacancies in this research project for participants?
"Correct, this clinical trial is still recruiting participants. The original posting went up on January 29th 2020 with the most recent edit taking place on September 15th of this year."
Does this particular research project test subjects who are elderly?
"Eligibility criteria for this study includes being between 18-80 years old."
Where are patients being treated with this experimental therapy?
"There are 13 sites enrolling patients for this trial, which are located in Rochester, Chicago, Boston and 10 other locations. If you wish to participate in this trial, it is ideal to select the clinic closest to your location to minimize travel requirements."
How many patients are included in this research project?
"Yes, that is correct. The clinical trial in question was originally posted on 1/29/2020 and updated as recently as 9/15/2022 according to the information available on clinicaltrials.gov. This particular trial is looking for 150 patients at 13 locations."
What is the general efficacy of Intensity-Modulated Radiation Therapy in cancer patients?
"City of Hope Comprehensive Cancer Center first studied Intensity-Modulated Radiation Therapy in 1997 and, since then, there have been 2042 completed clinical trials. As it stands, 1258 live studies are taking place with many of them based in Rochester, Minnesota."
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