Stereotactic Magnetic Resonance Guided Radiation Therapy

Dana-Farber Cancer Institute397 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

397

Conditions

Pancreas Cancer Lung Cancer Renal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Delivery Success Rate for SMART across multiple tumors-Phase I

Enrolling patients and delivering SMART on the MR Linac

Time frame: 1 year

Tumor visualization-Phase I

Assessing tumor using MR guidance before, during and after MR-guided treatment patient

Time frame: 1 Year

Plan creation-Phase I

Generating adaptive plans

Time frame: 1 Year

Rate of Improvement in Tumor Control-Phase II

Statistical power will be defined in each cohort individually and will be specific to each disease site tested.

Time frame: 1 Year

Secondary Outcomes

Number of Patients with Acute Toxicity-Phase I

Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART

Time frame: 90 Days

Duration of treatment-Phase 1

Duration of treatment with goal of \>80% of cases treated within 90 minutes

Time frame: 90 Days

Number of treatment fractions-Phase1

Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART

Time frame: 90 Days

Number of Participants with long term toxicity-Phase II

assessing long-term (12 month) toxicity in patients receiving SMART

Time frame: 365 Days

Disease Specific Survival Rate-Phase II

Kaplan-Meier curve estimates

Time frame: 365 Days

Overall Survival Rate-Phase II

Kaplan-Meier curve estimates

Time frame: 365

Stereotactic Magnetic Resonance Guided Radiation Therapy

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts