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A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)


Description

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer. * The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. * Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measuresThis 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 to treat cancer. The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer. In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Trial Eligibility

Inclusion Criteria: * Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details. * Tumor size ≤ 7cm * 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. * Specific eligibility requirements for each disease site with be covered in each specific cohort. Exclusion Criteria: * Specific exclusion requirements for each disease site with be covered in each specific cohort * History of allergic reactions attributed to gadolinium-based IV contrast. -- Note: If a patient will not receive contrast, this is not applicable * Pregnant women are excluded from this study. * Severe claustrophobia or anxiety * Participants who cannot undergo an MRI

Study Info

Organization

Dana-Farber Cancer Institute


Primary Outcome

Delivery Success Rate for SMART across multiple tumors-Phase I


Outcome Timeframe 1 year

NCTID NCT04115254

Phases NA

Primary Purpose TREATMENT

Start Date 2019-10-22

Completion Date 2028-06

Enrollment Target 397

Interventions

RADIATION MR-guided Linac

Locations Recruiting

Brigham & Women's Hospital

United States, Massachusetts, Boston


Dana Farber Cancer Institute

United States, Massachusetts, Boston


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