Stereotactic Magnetic Resonance Guided Radiation Therapy
Conditions
Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases, Oligoprogressive Nodal Metastases, Metachronous Nodal Metastases, Synchronous Nodal Metastases, Mesothelioma, Spine Metastases, Brain Metastases, Borderline Resectable Pancreatic CarcinomaSummary
This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.* The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. * Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures
Detailed Description
This research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation to treat cancer.
The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.
In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Jonathan Leeman, MD
Principal Investigator
- Jonathan Leeman, MD
Status
- RECRUITING
Contact Person
- Jonathan Leeman, MD
Principal Investigator
- Jonathan Leeman, MD
Eligibility Criteria
Inclusion Criteria:
* Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.
* Tumor size ≤ 7cm
* Age 18 years of older.
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Ability to understand and the willingness to sign a written informed consent document.
* Specific eligibility requirements for each disease site with be covered in each specific cohort.
Exclusion Criteria:
* Specific exclusion requirements for each disease site with be covered in each specific cohort
* History of allergic reactions attributed to gadolinium-based IV contrast.
-- Note: If a patient will not receive contrast, this is not applicable
* Pregnant women are excluded from this study.
* Severe claustrophobia or anxiety
* Participants who cannot undergo an MRI
Study Plan
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes
EXPERIMENTAL
SMART will be administered per each individual disease site standards
RADIATION:
MR-guided LinacDescription:
Radiation will be delivered on an MR-guided Linear Accelerator
Outcome Measures
Primary Outcome Measures
Delivery Success Rate for SMART across multiple tumors-Phase I
Tumor visualization-Phase I
Plan creation-Phase I
Rate of Improvement in Tumor Control-Phase II
Secondary Outcome Measures
Number of Patients with Acute Toxicity-Phase I
Duration of treatment-Phase 1
Number of treatment fractions-Phase1
Number of Participants with long term toxicity-Phase II
Disease Specific Survival Rate-Phase II
Overall Survival Rate-Phase II
Timeline
Last Updated
November 5, 2024Start Date
October 3, 2019Today
January 16, 2025Completion Date ( Estimated )
June 1, 2028
Sponsors of this trial
Lead Sponsor
Dana-Farber Cancer Institute