Prostate Cancer Clinical Trial

Stereotactic Magnetic Resonance Guided Radiation Therapy

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

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Full Description

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 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.

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Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

397

Study ID:

NCT04115254

Recruitment Status:

Suspended

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

397

Study ID:

NCT04115254

Recruitment Status:

Suspended

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

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