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Stereotactic Magnetic Resonance Guided Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115254
Recruitment Status : Suspended (MR-Linac temporarily moved off-line)
First Posted : October 3, 2019
Last Update Posted : October 30, 2023
Sponsor:
Information provided by (Responsible Party):
Jonathan Leeman, MD, Dana-Farber Cancer Institute

Study Description
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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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 397 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

Arms and Interventions
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Arm Intervention/treatment
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes
SMART will be administered per each individual disease site standards
 Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator


Outcome Measures
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Primary Outcome Measures :
  1. Delivery Success Rate for SMART across multiple tumors-Phase I [ Time Frame: 1 year ]
    Enrolling patients and delivering SMART on the MR Linac

  2. Tumor visualization-Phase I [ Time Frame: 1 Year ]
    Assessing tumor using MR guidance before, during and after MR-guided treatment patient

  3. Plan creation-Phase I [ Time Frame: 1 Year ]
    Generating adaptive plans

  4. 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 :
  1. 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

  2. Duration of treatment-Phase 1 [ Time Frame: 90 Days ]
    Duration of treatment with goal of >80% of cases treated within 90 minutes

  3. 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

  4. Number of Participants with long term toxicity-Phase II [ Time Frame: 365 Days ]
    assessing long-term (12 month) toxicity in patients receiving SMART

  5. Disease Specific Survival Rate-Phase II [ Time Frame: 365 Days ]
    Kaplan-Meier curve estimates

  6. Overall Survival Rate-Phase II [ Time Frame: 365 ]
    Kaplan-Meier curve estimates


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

  • 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
Contacts and Locations
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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


Locations
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United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Jonathan Leeman, MD Brigham and Women's Hospital
More Information
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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: October 30, 2023
Last Verified: October 2023
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

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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:
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