RecruitingNot ApplicableNCT04115254

Stereotactic Magnetic Resonance Guided Radiation Therapy

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


Sponsor

Dana-Farber Cancer Institute

Enrollment

397 participants

Start Date

Oct 22, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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 measures


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

Interventions

RADIATIONMR-guided Linac

Radiation will be delivered on an MR-guided Linear Accelerator


Locations(2)

Brigham & Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04115254


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