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

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


  • Org Study ID: 19-665
  • Secondary ID:
  • NCT ID: NCT04368702
  • NCT Alias:
  • Sponsor: Dana-Farber Cancer Institute - Other
  • Source: 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.

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.

Overal Status Start Date Phase Study Type
Recruiting May 1, 2021 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of Patients and delivering MR-image guided radiation-Phase I

Primary Outcome 1 - Time Frame: 5 weeks

Primary Outcome 2 - Measure: Tumor Assessment with MR Guidance-Phase I

Primary Outcome 2 - Time Frame: 5 weeks

Primary Outcome 3 - Measure: Patient reported outcomes (PROMs) -Phase II

Primary Outcome 3 - Time Frame: 1 year

Primary Outcome 4 - Measure: 1-year tumor control-Phase II

Primary Outcome 4 - Time Frame: 1 year

Primary Outcome 5 - Measure: Rate of Pathologic complete response-Gastric

Primary Outcome 5 - Time Frame: 1 year

Condition:

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

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)
r/> - 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Raymond Mak, MD

Role: Principal Investigator

Affiliation: Dana-Farber Cancer Institute

Overall Contact

Name: Raymond Mak, MD

Phone: 6177328651

Email: rmak@partners.org

Locations

Facility Status Contact
Brigham & Women's Hospital
Boston, Massachusetts 02115
United States
Recruiting Raymond Mak, MD

Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Recruiting Raymond Mak, MD