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

INTRODUCTION

  • Org Study ID: 19-665
  • Secondary ID: N/A
  • NTC ID: NCT04368702
  • Sponsor: 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.

  • Overall Status
    Recruiting
  • Start Date
    May 1, 2021
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 5 weeks

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

Primary Outcome 2 - Timeframe: 5 weeks

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

Primary Outcome 3 - Timeframe: 1 year

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

Primary Outcome 4 - Timeframe: 1 year

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

Primary Outcome 5 - Timeframe: 1 year

CONDITION

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

ELIGIBILITY

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

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

LOCATION

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

Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Status: Recruiting Contact: Principal Investigator
Raymond Mak, MD