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SBRT + Immunotherapy for Mesothelioma
Phase 1
Recruiting
Led By William G Breen
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has received or is planning to receive ICI for mesothelioma
Histological confirmation of pleural mesothelioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is studying how well stereotactic body radiation therapy and immunotherapy work in treating patients with mesothelioma.
Who is the study for?
Adults with confirmed pleural mesothelioma, who can undergo stereotactic body radiation therapy (SBRT) and immunotherapy. Participants must be able to give consent, follow up at the institution, have an ECOG performance status of ≤2, not be pregnant or nursing, and agree to use effective birth control.Check my eligibility
What is being tested?
The trial is testing how well patients with mesothelioma respond to a combination of high-precision radiation therapy called SBRT and immune-boosting treatments known as immunotherapy. The goal is to see if this combo improves tumor response while minimizing side effects.See study design
What are the potential side effects?
Potential side effects may include damage to normal tissues near the treated area due to radiation, typical reactions from immunotherapy like flu-like symptoms, fatigue, skin reactions, potential hormonal changes from birth control methods used during the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving or will receive immune therapy for mesothelioma.
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My cancer is confirmed as pleural mesothelioma.
Select...
I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor
Secondary outcome measures
Incidence of acute toxicity
Incidence of late toxicity
Progression-free survival (PFS)
Other outcome measures
Overall survival (OS)
Patterns of failure
Quality of life (QOL)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT, immunotherapy)Experimental Treatment3 Interventions
Patients undergo 3-5 daily fractions of SBRT in the absence of disease progression or unacceptable toxicity. Patients also receive immunotherapy at the discretion of the treating medical oncologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,063 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,647 Total Patients Enrolled
William G BreenPrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
170 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planning to undergo SBRT for mesothelioma.I am currently breastfeeding.I am receiving or will receive immune therapy for mesothelioma.My cancer is confirmed as pleural mesothelioma.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SBRT, immunotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities available for individuals to take part in this trial?
"Affirmative. Clinicaltrials.gov records that this clinical trial was inaugurated on July 12th 2021 and the latest revision occurred on December 1st 2021. The study is searching for 20 patients from one location to participate."
Answered by AI
Has Stereotactic Body Radiation Therapy been granted official clearance by the FDA?
"With limited clinical data available for both its efficacy and safety, our team at Power gave Stereotactic Body Radiation Therapy a score of 1."
Answered by AI
How many individuals are being included in the research experiment?
"Affirmative. According to clinicaltrials.gov, this trial is still calling for volunteers. The initial posting of the study was on July 12th 2021 and it has been most recently updated on December 1st 2021. Currently, 20 individuals are needed from a single site."
Answered by AI
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