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Radiation Therapy
MRI-Guided Radiation Therapy for Cancer
N/A
Recruiting
Led By Jonathan Leeman, MD
Research Sponsored by Dana-Farber Cancer Institute
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 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new radiation therapy that uses MRIs to better target cancer cells. The first phase will test if it is safe andPhase 2 will test if it is effective.
Who is the study for?
This trial is for adults with certain types of cancer, including oral, lung, kidney, prostate cancers and more. Participants must be over 18 years old with tumors ≤7cm that need stereotactic body radiation therapy. They should understand the study and agree to participate by signing a consent form. People who are pregnant or have severe claustrophobia/anxiety or allergies to MRI contrast agents (unless not receiving contrast) cannot join.
What is being tested?
The trial is testing Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART). Phase I checks if SMART can be safely given to patients with cancer while Phase II looks at how well it controls tumors and improves patient-reported outcomes.
What are the potential side effects?
While specific side effects aren't listed here, generally radiation therapy may cause fatigue, skin reactions in treated areas, mild swelling or pain around the tumor site, nausea depending on the area being treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Delivery Success Rate for SMART across multiple tumors-Phase I
Plan creation-Phase I
Rate of Improvement in Tumor Control-Phase II
+1 moreSecondary study objectives
Disease Specific Survival Rate-Phase II
Duration of treatment-Phase 1
Number of Participants with long term toxicity-Phase II
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
19Treatment groups
Experimental Treatment
Group I: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft TissueExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group II: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--SpineExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group III: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney TumorsExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group IV: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--RenalExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group V: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate BoostExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group VI: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--ProstateExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group VII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung CancerExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group VIII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-IrradiationExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group IX: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--PancreaticExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group X: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft TissueExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XI: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic NodesExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--MesotheliomaExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XIII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph NodesExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XIV: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver MetastasesExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XV: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central LungExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XVI: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain MetastasesExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XVII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable PancreasExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XVIII: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal MetastasesExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Group XIX: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/PelvisExperimental Treatment1 Intervention
SMART will be administered per each individual disease site standards
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
356,814 Total Patients Enrolled
9 Trials studying Mesothelioma
624 Patients Enrolled for Mesothelioma
Jonathan Leeman, MDPrincipal Investigator - Brigham and Women's Hospital
Dana-Farber Cancer Institute
3 Previous Clinical Trials
371 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The exclusion criteria for each group of participants with the same disease will be explained separately.Women who are currently pregnant.You experience severe anxiety or claustrophobia.You are not able to have an MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes
- Group 2: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis
- Group 3: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
- Group 4: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors
- Group 5: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
- Group 6: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases
- Group 7: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost
- Group 8: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine
- Group 9: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer
- Group 10: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas
- Group 11: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes
- Group 12: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases
- Group 13: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases
- Group 14: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation
- Group 15: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
- Group 16: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue
- Group 17: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue
- Group 18: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate
- Group 19: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma
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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