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Immunotherapy + Chemotherapy + Surgery +/- Radiation for Mesothelioma
Study Summary
This trial is testing immunotherapy, chemotherapy, and surgery with or without radiation therapy to see how well it works in treating pleural malignant mesothelioma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am fully active or restricted in physically strenuous activity but can do light work.If you need a hearing aid or have trouble hearing, you need to have a hearing test done within 28 days before joining the study.I haven't had any cancer treatment or experimental drugs in the last 28 days.You cannot have had severe allergic reactions to certain types of medications in the past.I stopped radiation therapy early due to side effects or other reasons.Your kidney function, as measured by creatinine levels, should be within a certain range.I am not allergic to medications made in Chinese hamster ovary cells or any part of atezolizumab.I haven't taken medication for an autoimmune disease in the last 2 years.I have never had lung conditions like pulmonary fibrosis or pneumonitis.I do not have active hepatitis B or C.I have not received a live flu vaccine within the last 4 weeks and won't during the study.My mesothelioma is confirmed by biopsy and is not sarcomatoid type.I've had a CT or PET/CT scan within the last 28 days.I had surgery to check for cancer spread in my chest and abdomen within the last 28 days.I've had a recent scan showing no cancer progression.Your liver function tests should be within a certain range, not higher than 3 times the upper limit of normal.I've seen a surgeon within the last 21 days who confirmed I can have surgery to remove my disease.I haven't had any severe infections or been hospitalized for infection complications in the last month.I have not had a bone marrow or organ transplant.I will be assessed by a radiation oncologist for therapy suitability within 14 days before my next registration step.I am fully active or restricted in physically strenuous activity but can do light work.My lung function test shows I can breathe out more than 35% of air in one second.My lung function test shows a DLCO value greater than 35%.I have completed at least two rounds of a specific three-drug cancer treatment.I've had surgery for my condition and healed, with or without radiation, and it's been less than 90 days since treatment.I am fully active or restricted in physically strenuous activity but can do light work.Your hemoglobin level is higher than 9 grams per deciliter, as checked within the last 28 days before enrolling in the study.Your absolute neutrophil count (ANC) is higher than 1,500 cells per microliter.I do not have active tuberculosis.Your platelet count is higher than 100,000 per microliter.My cancer's size or presence is confirmed by CT or MRI within the required time.I've had specific lung cancer surgery within the last 42 days and my cancer is at an early to mid-stage.I do not have serious heart problems.I registered between 21 and 90 days after my last pre-surgery cancer treatment.I have early-stage mesothelioma and am planning surgery to remove it.Your total bilirubin level should be less than 1.5 times the upper limit of normal.I've had a recent scan showing no cancer progression.I haven't had major surgery or radiation in the last 28 days.You cannot have HIV, and you don't need to be tested for HIV. If you have HIV, you cannot participate because it could affect your immune system and the medications you need.I have not received immunotherapy or chemotherapy for mesothelioma.
- Group 1: Treatment (chemotherapy, surgery, RT)
- 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 are the areas in North America where this research endeavor is taking place?
"At this time, 100 patients have enrolled in the study with locations including Saint Clare Hospital (Lakewood), OptumCare Cancer Care at MountainView (Las Vegas), and MD Anderson in Sugar Land. Additionally, there are an additional 100 sites recruiting participants."
Has the FDA sanctioned Radiation Therapy for use in treatments?
"Due to the preliminary nature of Radiation Therapy, its safety was rated 1 in our Power assessment. This is due to limited clinical evidence backing both efficacy and security at this time."
What medical conditions are typically treated with Radiation Therapy?
"Radiotherapy is commonly used in conjunction with pharmacological interventions to treat advanced testicular cancer, small cell lung cancer (SCLC), and other malignancies."
Is there still an opportunity to participate in this experiment?
"The evidence on clinicaltrials.gov shows that this particular study is not currently searching for participants, despite being originally published in November of 2017 and edited last October. However, there are an abundance of other medical trials recruiting patients at the moment with a total number amounting to 2758."
What other investigations have been conducted to assess the efficacy of Radiation Therapy?
"Currently, there are 1143 studies investigating Radiation Therapy of which 363 have entered Phase 3. The bulk of these trials can be found in Shanghai, but 64168 medical centres around the world are conducting research into this treatment."
What is the current enrolment rate for this clinical experiment?
"This study is no longer accepting participants; it was first posted on November 3rd, 2017 and last updated on October 25th 2022. For those seeking alternative trials, 1615 studies are currently recruiting patients with Stage II Pleural Malignant Mesothelioma AJCC V7 and 1143 for Radiation Therapy."
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