Stereotactic Magnetic Resonance Guided Radiation Therapy

• ClinicalTrials.gov Identifier: NCT04115254
• Recruitment Status: Suspended
• First Posted: October 3, 2019
• Last Update Posted: October 30, 2023
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Jonathan Leeman, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: September 26, 2019
• First Posted Date: October 3, 2019
• Last Update Posted Date: October 30, 2023
• Actual Study Start Date: October 22, 2019
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 2, 2019)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 2, 2019)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stereotactic Magnetic Resonance Guided Radiation Therapy
• Official Title: A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

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

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• 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

Intervention

Radiation: MR-guided Linac

Radiation will be delivered on an MR-guided Linear Accelerator

Study Arms

• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac
• 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
  Intervention: Radiation: MR-guided Linac
• 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
  Intervention: Radiation: MR-guided Linac
• Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes
  SMART will be administered per each individual disease site standards
  Intervention: Radiation: MR-guided Linac

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: October 9, 2023): 397
• Original Estimated Enrollment (submitted: October 2, 2019): 1000
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04115254
• Other Study ID Numbers: 19-353
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: Jonathan Leeman, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Daniel Cagney, MD, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jonathan Leeman, MD; Brigham and Women's Hospital

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: October 2023