Stereotactic Magnetic Resonance Guided Radiation Therapy
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| ClinicalTrials.gov Identifier: NCT04115254 |
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Recruitment Status :
Recruiting
First Posted : October 3, 2019
Last Update Posted : September 27, 2022
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Sponsor:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Jonathan Leeman, MD, Dana-Farber Cancer Institute
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Brief Summary:
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 Carcinoma | Radiation: MR-guided Linac | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | All participants will be assigned to one treatment arm only depending on their cancer type, and will be taken off study once treatment and follow up are complete. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART) |
| Actual Study Start Date : | October 22, 2019 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | June 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
MRI Scans
| Arm | Intervention/treatment |
|---|---|
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION-Pancreatic
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION-Renal
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION-Lung
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION-ADRENAL METASTASES
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION-LIVER METASTASES
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- METACHRONOUS OLIGOMETASTATIC NODES
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- OLIGOPROGRESSIVE OLIGOMETASTATIC NODES/SOFT TISSUE
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- SYNCHRONOUS OLIGOMETASTATIC NODES/SOFT TISSUE METASTASES
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- PROSTATE CANCER
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- BORDERLINE RESECTABLE PANCREAS
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- BRAIN METASTASIS
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- MESOTHELIOMA
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- PROSTATE BOOST
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- PELVIC RE-IRRADIATION
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- SPINE
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE1:SBRT MR IMAGE GUIDANCE/ADAPTATION-Single-Fraction Precision Adaptive Radiation Kidney Tumors
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE1:SBRT MR IMAGE GUIDANCE/ADAPTATION- 1/3 Fraction for Oligometastatases in the Abdomen & Pelvis
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
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Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION- Post-Operative Radiation Therapy Lung Cancer
SMART will be administered per each individual disease site standards
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Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator |
Primary Outcome Measures :
- Delivery Success Rate for SMART across multiple tumors-Phase I [ Time Frame: 1 year ]Enrolling patients and delivering SMART on the MR Linac
- Tumor visualization-Phase I [ Time Frame: 1 Year ]Assessing tumor using MR guidance before, during and after MR-guided treatment patient
- Plan creation-Phase I [ Time Frame: 1 Year ]Generating adaptive plans
- Rate of Improvement in Tumor Control-Phase II [ Time Frame: 1 Year ]Statistical power will be defined in each cohort individually and will be specific to each disease site tested.
Secondary Outcome Measures :
- Number of Patients with Acute Toxicity-Phase I [ Time Frame: 90 Days ]Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART
- Duration of treatment-Phase 1 [ Time Frame: 90 Days ]Duration of treatment with goal of >80% of cases treated within 90 minutes
- Number of treatment fractions-Phase1 [ Time Frame: 90 Days ]Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART
- Number of Participants with long term toxicity-Phase II [ Time Frame: 365 Days ]assessing long-term (12 month) toxicity in patients receiving SMART
- Disease Specific Survival Rate-Phase II [ Time Frame: 365 Days ]Kaplan-Meier curve estimates
- Overall Survival Rate-Phase II [ Time Frame: 365 ]Kaplan-Meier curve estimates
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115254
Contacts
| Contact: Jonathan Leeman, MD | 617-732-6452 | JONATHANE_LEEMAN@DFCI.HARVARD.EDU |
Locations
| United States, Massachusetts | |
| Brigham & Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Jonathan Leeman, MD | |
| Principal Investigator: Jonathan Leeman, MD | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Jonathan Leeman, MD | |
| Principal Investigator: Jonathan Leeman, MD | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
| Principal Investigator: | Jonathan Leeman, MD | Brigham and Women's Hospital |
| Responsible Party: | Jonathan Leeman, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT04115254 |
| Other Study ID Numbers: |
19-353 |
| First Posted: | October 3, 2019 Key Record Dates |
| Last Update Posted: | September 27, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Dr. Jonathan Leeman (jonathane_leeman@dfci.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Data can be shared no earlier than 1 year following the date of publication |
| Access Criteria: | BWH - Contact the Partners Innovations team at http://www.partners.org/innovation |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Jonathan Leeman, MD, Dana-Farber Cancer Institute:
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Magnetic Resonance Imaging (MRI) MRIdian Linear Accelerator Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metastases Prostate Cancer |
Liver Metastases Oligoprogressive Metachronous Synchronous Spine Prostate Boost Pelvic Re Irradiation |
Additional relevant MeSH terms:
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Prostatic Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Mesothelioma Pancreatic Neoplasms Kidney Neoplasms Carcinoma, Renal Cell Neoplasms by Site Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases |
Prostatic Diseases Male Urogenital Diseases Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Digestive System Neoplasms Endocrine Gland Neoplasms |