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NBTXR3 + Radiation Therapy for Lung Cancer
Study Summary
This trial is testing a new cancer treatment that combines a new drug with radiation therapy. The goal is to see if the new treatment is more effective at killing cancer cells than radiation therapy alone.
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 using effective birth control methods during the study.I am not pregnant or breastfeeding.I haven't taken cancer or immunotherapy drugs in the last 3 weeks.My last radiation treatment was over 6 months ago.I do not have any severe illnesses that could interfere with the treatment.I have cognitive impairments.I can take care of myself and am up and about more than half of the day.I have never had severe lung or esophagus problems due to drugs, radiation, or disease.My doctor says I cannot have surgery for my condition.I do not have an active, uncontrolled HIV or hepatitis B/C infection.My lab results are good enough for radiation therapy, as confirmed by my doctor.My lung cancer has returned in the same area after radiation, and it will be confirmed before treatment.I am not currently on any cancer treatments or participating in another cancer trial.I have no active cancer besides my lung cancer, or any other cancers I've had are in remission.My cancer can be measured on scans and any lymph node cancer is at least 15 mm across.At the time of screening, your blood test results need to show certain values within a specific range, and you need to meet other medical criteria. Also, you need to understand and agree to be part of the study.I am willing to have a special injection guided by a lung scan or bronchoscopy.I can have up to 4 lung lesions treated, including at least one that will be reirradiated.I am 18 years old or older.My recurring cancer is within the area previously treated with radiation.My stage IV cancer has 3 or fewer lesions, not counting the main tumor.
- Group 1: Treatment (NBTXR3, 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
To what degree could Radiation Therapy be detrimental to an individual's health?
"Radiation Therapy was assigned a score of 1 because there is minimal evidence on its safety and efficacy, as this study is classified as Phase 1."
Are researchers currently enlisting participants for this trial?
"According to clinicaltrials.gov, this medical trial is presently seeking participants. The first posting was made on the 10th of February 2021 and the most recent amendment occurred on August 3rd 2021."
What are the main goals of this experiment?
"This trial seeks to assess dose limiting toxicity (DLT) in Cohort 1 over a four-week period post RT. Secondary objectives include measuring overall survival using the Kaplan-Meier method, objective response rate according to RECIST and irRECIST criteria, and local progression free survival also determined with the Kaplan-Meier approach."
What is the participant figure for this research endeavor?
"Affirmative. According to the clinicaltrials.gov page, this research study first went live on February 10th 2021 and is currently in search of 24 participants across one medical site."
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