Gastric CancerCONFIRMNCT04368702
CONFIRM: Magnetic Resonance Guided Radiation Therapy
A study testing Viewray MRIdian® Linac in people with Gastric Cancer and Invasive Breast Cancer, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer
- What is being tested?
- Viewray MRIdian® Linac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2021to 18 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Raymond Mak, MD
Raymond Mak, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Raymond Mak, MD
Raymond Mak, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Mantle Cell Lymphoma, Larynx Cancer, Bladder Cancer
- Being tested
- Viewray MRIdian® Linac
- Keywords
- Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Lymphoma, Larynx, Bladder
- Medical subject headings
- Stomach Neoplasms, Breast Carcinoma In Situ, Lymphoma, Mantle-Cell, Laryngeal Neoplasms, Urinary Bladder Neoplasms, Lymphoma, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viewray MRIdian® LinacRadiation
MR-image guided radiation will be administered per disease site standards.
| Study group | Role | What they receive |
|---|---|---|
| Phase I - Gastric Cancer | Experimental | 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 Receives: Radiation: Viewray MRIdian® Linac |
| Phase I - Breast Cancer | Experimental | 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 Receives: Radiation: Viewray MRIdian® Linac |
| Phase I - Mantle Cell Lymphoma | Experimental | 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 Receives: Radiation: Viewray MRIdian® Linac |
| Phase I - Larynx | Experimental | 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 Receives: Radiation: Viewray MRIdian® Linac |
| Phase I - Bladder | Experimental | 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 Receives: Radiation: Viewray MRIdian® Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 1 year
1-year tumor control-Phase II
Tumor response 1 year after radiation treatment
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (7)
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.
Measured: 90 Days
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
CTCAE version 5.0.
Measured: 1 year
Duration of treatment with goal of >80% of cases treated within 90 minutes
Total time of treatment for each fraction
Measured: 7 weeks
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
Measured: 5 Weeks
Progression Free Survival
Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.
Measured: 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
The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Measured: 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
Evaluation of tumor response following treatment
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 May 2021
- Primary completion18 Jun 2029 (estimated)
- Study completion18 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Mak, Brigham and Women's Hospital
- Investigators
- Raymond Mak, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368702
- Sponsor's protocol ID
- 19-665
- Acronym
- CONFIRM
- Status last verified
- Jan 2026
- First submitted
- 22 Apr 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
- ClinicalTrials.gov ID
- NCT04368702
- Acronym / sponsor ID
- CONFIRM / 19-665
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 18 Jun 2029 (estimated)
- Study completion
- 18 Jun 2029 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase I - Gastric Cancer | Experimental | Radiation: Viewray MRIdian® LinacThe 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 |
| Phase I - Breast Cancer | Experimental | Radiation: Viewray MRIdian® LinacThe 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 |
| Phase I - Mantle Cell Lymphoma | Experimental | Radiation: Viewray MRIdian® LinacThe 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 |
| Phase I - Larynx | Experimental | Radiation: Viewray MRIdian® LinacThe 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 |
| Phase I - Bladder | Experimental | Radiation: Viewray MRIdian® LinacThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viewray MRIdian® LinacMR-image guided radiation will be administered per disease site standards. | Radiation | Phase I - Bladder, Phase I - Breast Cancer, Phase I - Gastric Cancer, Phase I - Larynx, Phase I - Mantle Cell Lymphoma |
Primary outcome
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.
7 secondary outcomes
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Time frame: 90 Days
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Time frame: 1 year
Duration of treatment with goal of >80% of cases treated within 90 minutes
Time frame: 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
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
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
Characterizing MRI-based tumor alterations/changes following MR-image guided radiation
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond Mak, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viewray MRIdian® Linac in people with Gastric Cancer and Invasive Breast Cancer, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Mak, MD (6177328651, rmak@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients and delivering MR-image guided radiation-Phase I (time frame: 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.