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Stereotactic Magnetic Resonance Guided Radiation Therapy

Primary Purpose

Pancreas Cancer, Lung Cancer, Renal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MR-guided Linac

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham & Women's HospitalRecruiting
Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm Type

Experimental

Arm Label

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes

Arm Description

SMART will be administered per each individual disease site standards

Outcomes

Primary Outcome Measures

Delivery Success Rate for SMART across multiple tumors-Phase I

Enrolling patients and delivering SMART on the MR Linac

Tumor visualization-Phase I

Assessing tumor using MR guidance before, during and after MR-guided treatment patient

Plan creation-Phase I

Generating adaptive plans

Rate of Improvement in Tumor Control-Phase II

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

Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART

Duration of treatment-Phase 1

Duration of treatment with goal of >80% of cases treated within 90 minutes

Number of treatment fractions-Phase1

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

assessing long-term (12 month) toxicity in patients receiving SMART

Disease Specific Survival Rate-Phase II

Kaplan-Meier curve estimates

Overall Survival Rate-Phase II

Kaplan-Meier curve estimates

Full Information

NCT ID

NCT04115254

First Posted

September 26, 2019

Last Updated

October 9, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04115254

Brief Title

Stereotactic Magnetic Resonance Guided Radiation Therapy

Official Title

A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 22, 2019 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

397 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Arm Title

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes

Arm Type

Experimental

Arm Description

SMART will be administered per each individual disease site standards

Intervention Type

Radiation

Intervention Name(s)

MR-guided Linac

Intervention Description

Radiation will be delivered on an MR-guided Linear Accelerator

Primary Outcome Measure Information:

Title

Delivery Success Rate for SMART across multiple tumors-Phase I

Description

Enrolling patients and delivering SMART on the MR Linac

Time Frame

1 year

Title

Tumor visualization-Phase I

Description

Assessing tumor using MR guidance before, during and after MR-guided treatment patient

Time Frame

1 Year

Title

Plan creation-Phase I

Description

Generating adaptive plans

Time Frame

1 Year

Title

Rate of Improvement in Tumor Control-Phase II

Description

Statistical power will be defined in each cohort individually and will be specific to each disease site tested.

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

Number of Patients with Acute Toxicity-Phase I

Description

Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART

Time Frame

90 Days

Title

Duration of treatment-Phase 1

Description

Duration of treatment with goal of >80% of cases treated within 90 minutes

Time Frame

90 Days

Title

Number of treatment fractions-Phase1

Description

Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART

Time Frame

90 Days

Title

Number of Participants with long term toxicity-Phase II

Description

assessing long-term (12 month) toxicity in patients receiving SMART

Time Frame

365 Days

Title

Disease Specific Survival Rate-Phase II

Description

Kaplan-Meier curve estimates

Time Frame

365 Days

Title

Overall Survival Rate-Phase II

Description

Kaplan-Meier curve estimates

Time Frame

365

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan Leeman, MD

Phone

617-732-6452

JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Leeman, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham & Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan Leeman, MD

First Name & Middle Initial & Last Name & Degree

Jonathan Leeman, MD

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan Leeman, MD

First Name & Middle Initial & Last Name & Degree

Jonathan Leeman, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

BWH - Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

Stereotactic Magnetic Resonance Guided Radiation Therapy

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