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CONFIRM: Magnetic Resonance Guided Radiation Therapy (CONFIRM)

Primary Purpose

Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viewray MRIdian® Linac
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Lymphoma, Larynx, Bladder

Eligibility Criteria

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

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

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 Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase I - Gastric Cancer

Phase I - Breast Cancer

Phase I - Mantle Cell Lymphoma

Phase I - Larynx

Phase I - Bladder

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Patients and delivering MR-image guided radiation-Phase I
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
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
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
Tumor response 1 year after radiation treatment
Rate of Pathologic complete response-Gastric
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

Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
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.
CTCAE version 5.0.
Duration of treatment with goal of >80% of cases treated within 90 minutes
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.
Importance of MR-guidance
Progression Free Survival
Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.
Overall Survival
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
Evaluation of tumor response following treatment

Full Information

First Posted
April 22, 2020
Last Updated
September 12, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04368702
Brief Title
CONFIRM: Magnetic Resonance Guided Radiation Therapy
Acronym
CONFIRM
Official Title
Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 18, 2024 (Anticipated)
Study Completion Date
June 18, 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
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Mantle Cell Lymphoma, Larynx Cancer, Bladder Cancer
Keywords
Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Lymphoma, Larynx, Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase I - Gastric Cancer
Arm Type
Experimental
Arm Description
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
Arm Title
Phase I - Breast Cancer
Arm Type
Experimental
Arm Description
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
Arm Title
Phase I - Mantle Cell Lymphoma
Arm Type
Experimental
Arm Description
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
Arm Title
Phase I - Larynx
Arm Type
Experimental
Arm Description
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
Arm Title
Phase I - Bladder
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Viewray MRIdian® Linac
Intervention Description
MR-image guided radiation will be administered per disease site standards.
Primary Outcome Measure Information:
Title
Number of Patients and delivering MR-image guided radiation-Phase I
Description
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac
Time Frame
5 weeks
Title
Tumor Assessment with MR Guidance-Phase I
Description
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.
Time Frame
5 weeks
Title
Patient reported outcomes (PROMs) -Phase II
Description
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.
Time Frame
1 year
Title
1-year tumor control-Phase II
Description
Tumor response 1 year after radiation treatment
Time Frame
1 year
Title
Rate of Pathologic complete response-Gastric
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Description
Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.
Time Frame
90 Days
Title
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Description
CTCAE version 5.0.
Time Frame
1 year
Title
Duration of treatment with goal of >80% of cases treated within 90 minutes
Description
Total time of treatment for each fraction
Time Frame
7 weeks
Title
Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.
Description
Importance of MR-guidance
Time Frame
5 Weeks
Title
Progression Free Survival
Description
Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.
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
Title
Overall Survival
Description
The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
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
Title
Characterizing MRI-based tumor alterations/changes following MR-image guided radiation
Description
Evaluation of tumor response following treatment
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Mak, MD
Phone
6177328651
Email
rmak@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Mak, MD
Organizational Affiliation
Dana-Farber Cancer Institute
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
Raymond Mak, MD
First Name & Middle Initial & Last Name & Degree
Raymond Mak, 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
Raymond Mak, MD
First Name & Middle Initial & Last Name & Degree
Raymond Mak, 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 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

Learn more about this trial

CONFIRM: Magnetic Resonance Guided Radiation Therapy

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