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CONFIRM: Magnetic Resonance Guided Radiation Therapy (CONFIRM)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368702
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Daniel Cagney, MD, Dana-Farber Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Invasive Breast Cancer in Situ Breast Cancer Radiation: Viewray MRIdian® Linac Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : June 18, 2024
Estimated Study Completion Date : June 18, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 1-year tumor control-Phase II [ Time Frame: 1 year ]
    Tumor response 1 year after radiation treatment

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0. [ Time Frame: 1 year ]
    CTCAE version 5.0.

  3. Duration of treatment with goal of >80% of cases treated within 90 minutes [ Time Frame: 7 weeks ]
    Total time of treatment for each fraction

  4. 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. 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.

  6. 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.

  7. Characterizing MRI-based tumor alterations/changes following MR-image guided radiation [ Time Frame: 1 Year ]
    Evaluation of tumor response following treatment



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 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

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): NCT04368702


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
Boston, Massachusetts, United States, 02115
Contact: Daniel Cagney, MD         
Principal Investigator: Daniel Cagney, MD         
Dana Farber Cancer Institute
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 Dana-Farber Cancer Institute
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Responsible Party: Daniel Cagney, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04368702    
Other Study ID Numbers: 19-665
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: January 6, 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 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.
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: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Daniel Cagney, MD, Dana-Farber Cancer Institute:
Gastric Cancer
Invasive Breast Cancer
in Situ Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Stomach Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type