CONFIRM: Magnetic Resonance Guided Radiation Therapy (CONFIRM)

November 9, 2023 updated by: Raymond Mak, MD, Dana-Farber Cancer Institute

Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.

In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • Follow up visits
  • Questionnaires

This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is being studied.

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. Investigators at other hospitals and academic centers are already using this type of radiation.

The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed malignancy requiring radiation
  • 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.
  • Any further criteria listed in the specific disease site cohort

Exclusion Criteria

  • History of allergic reactions attributed to gadolinium-based IV contrast

    -- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility

  • Severe claustrophobia or anxiety
  • Participants who cannot undergo an MRI
  • Any other exclusion criteria listed in the specific disease site cohort

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I - Gastric Cancer

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires
Radiation: Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.
Experimental: Phase I - Breast Cancer

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires
Radiation: Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.
Experimental: Phase I - Mantle Cell Lymphoma

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires
Radiation: Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.
Experimental: Phase I - Larynx

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires
Radiation: Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.
Experimental: Phase I - Bladder

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • MR-image guided radiation will be administered per disease site standards.
  • Follow up visits
  • Questionnaires
Radiation: Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients and delivering MR-image guided radiation-Phase I
Time Frame: 5 weeks
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac
5 weeks
Tumor Assessment with MR Guidance-Phase I
Time Frame: 5 weeks
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as assessing tumor using MR guidance before, during and after MR-guided treatment patient.
5 weeks
Patient reported outcomes (PROMs) -Phase II
Time Frame: 1 year
PROMs are collected at patient visits. PROMs will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS Global-10 metric collects information on symptoms and quality of life.
1 year
1-year tumor control-Phase II
Time Frame: 1 year
Tumor response 1 year after radiation treatment
1 year
Rate of Pathologic complete response-Gastric
Time Frame: 1 year
full pathological review of surgical specimen according to the AJCC Staging Classification, 8th edition. pCR will be defined as the absence of any viable tumor cells within the pathologic specimen.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Time Frame: 90 Days
Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.
90 Days
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Time Frame: 1 year
CTCAE version 5.0.
1 year
Duration of treatment with goal of >80% of cases treated within 90 minutes
Time Frame: 7 weeks
Total time of treatment for each fraction
7 weeks
Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.
Time Frame: 5 Weeks
Importance of MR-guidance
5 Weeks
Progression Free Survival
Time Frame: irst date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause up to 12 Months
Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.
irst date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause up to 12 Months
Overall Survival
Time Frame: irst date of protocol therapy to the date of death due to any cause. OS time will be censored at the date of last follow-up for patients still alive up to 1 year
The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
irst date of protocol therapy to the date of death due to any cause. OS time will be censored at the date of last follow-up for patients still alive up to 1 year
Characterizing MRI-based tumor alterations/changes following MR-image guided radiation
Time Frame: 1 Year
Evaluation of tumor response following treatment
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Raymond Mak, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

June 18, 2024

Study Completion (Estimated)

June 18, 2024

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Sponsor Investigator or designee. 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

DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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