CONFIRM: Magnetic Resonance Guided Radiation Therapy (CONFIRM)

• ClinicalTrials.gov Identifier: NCT04368702
• Recruitment Status: Suspended
• First Posted: April 30, 2020
• Last Update Posted: November 13, 2023
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Raymond Mak, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: April 22, 2020
• First Posted Date: April 30, 2020
• Last Update Posted Date: November 13, 2023
• Actual Study Start Date: May 1, 2021
• Estimated Primary Completion Date: June 18, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 28, 2020)

• 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.
• Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0. [ Time Frame: 1 year ]
  CTCAE version 5.0.
• Duration of treatment with goal of >80% of cases treated within 90 minutes [ Time Frame: 7 weeks ]
  Total time of treatment for each fraction
• 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
• 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.
• 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.
• Characterizing MRI-based tumor alterations/changes following MR-image guided radiation [ Time Frame: 1 Year ]
  Evaluation of tumor response following treatment

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

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
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Gastric Cancer
• Invasive Breast Cancer
• in Situ Breast Cancer
• Mantle Cell Lymphoma
• Larynx Cancer
• Bladder Cancer

Intervention

Radiation: Viewray MRIdian® Linac

MR-image guided radiation will be administered per disease site standards.

Study Arms

• 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
  Intervention: Radiation: Viewray MRIdian® Linac
• 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
  Intervention: Radiation: Viewray MRIdian® Linac
• 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
  Intervention: Radiation: Viewray MRIdian® Linac
• 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
  Intervention: Radiation: Viewray MRIdian® Linac
• 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
  Intervention: Radiation: Viewray MRIdian® Linac

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: May 28, 2021): 70
• Original Estimated Enrollment (submitted: April 28, 2020): 40
• Estimated Study Completion Date: June 18, 2024
• Estimated Primary Completion Date: June 18, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

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: NCT04368702
• Other Study ID Numbers: 19-665
• 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

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

• Current Responsible Party: Raymond Mak, 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: Raymond Mak, MD; Dana-Farber Cancer Institute

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