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Radiation Therapy
SMART for Lung Cancer
N/A
Recruiting
Led By Saumil Gandhi, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
This trial compares radiation therapy guided by MRI vs CT to see if it helps control central lung cancer.
Who is the study for?
This trial is for adults with central lung tumors close to critical structures who can sign consent. It's for those needing more than 10-15 radiation sessions if using CT-based therapy, and includes primary or metastatic lung cancer patients. Pregnant women, individuals unable to undergo MRI due to claustrophobia or metal implants, and those not using contraception are excluded.Check my eligibility
What is being tested?
The study tests Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) against conventional CT-guided therapy in controlling central lung cancer. The goal is to see if MRI guidance improves treatment precision and effectiveness compared to the usual method.See study design
What are the potential side effects?
Potential side effects of SMART may include skin reactions, fatigue, shortness of breath, coughing, chest pain, difficulty swallowing due to esophagus irritation from radiation exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)Experimental Treatment1 Intervention
Participants will receive treatment with the investigational MRI-guided radiation therapy.
Group II: Stage I-(Simulated Online Adaptive Planning)Experimental Treatment1 Intervention
Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,259 Total Patients Enrolled
Saumil Gandhi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
75 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You can't handle being in a tight space for an MRI scan, for example, if you have claustrophobia.The tumor is located very close to important structures in the chest.Two doctors specializing in chest radiation agree that you need to receive radiation treatments in more than 10-15 sessions using a specific type of radiation therapy.You have cancer that started in the lungs or cancer that has spread to the lungs from another part of the body.
Research Study Groups:
This trial has the following groups:- Group 1: Stage I-(Simulated Online Adaptive Planning)
- Group 2: Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)
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.
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