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Stereotactic Magnetic Resonance Guided Radiation Therapy

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ClinicalTrials.gov Identifier: NCT04115254
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Daniel Cagney, MD, Dana-Farber Cancer Institute

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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


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-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 2: SBRT REDUCED MARGINS, DOSE ESCALATION-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 2: SBRT REDUCED MARGINS, DOSE ESCALATION-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 2: SBRT REDUCED MARGINS, DOSE ESCALATION-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




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



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
  • 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
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Contact: Daniel Cagney, MD 617-732-7560 dcagney@partners.org

Locations
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United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Daniel Cagney, MD         
Principal Investigator: Daniel Cagney, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Daniel Cagney, MD Brigham and Women's Hospital
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Responsible Party: Daniel Cagney, 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: January 26, 2021
Last Verified: January 2021
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. Daniel Cagney (dcagney@bwh.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 Daniel Cagney, MD, Dana-Farber Cancer Institute:
Magnetic Resonance Imaging (MRI)
MRIdian Linear Accelerator
Pancreas Cancer
Lung Cancer
Renal Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type