NCT04115254 Stereotactic Magnetic Resonance Guided Radiation Therapy
| NCT ID | NCT04115254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 397 participants |
| Start Date | 2019-10-22 |
| Primary Completion | 2028-06 |
Trial Parameters
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Brief 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 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
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