Clinical trial NCT04115254: Stereotactic Magnetic Resonance Guided Radiation Therapy
Official title: A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Lung Cancer
Renal Cancer
Adrenal Metastases
Prostate Cancer
Liver Metastases
Oligoprogressive Nodal Metastases
Metachronous Nodal Metastases
Synchronous Nodal Metastases
Mesothelioma
Spine Metastases
Brain Metastases
Borderline Resectable Pancreatic Carcinoma
Keywords: Magnetic Resonance Imaging (MRI)
MRIdian Linear Accelerator
Pancreas Cancer
Lung Cancer
Renal Cancer
Adrenal Metastases
Prostate Cancer
Liver Metastases
Oligoprogressive
Metachronous
Synchronous
Spine
Prostate Boost
Pelvic Re Irradiation
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will be assigned to one treatment arm only depending on their cancer type, and will be taken off study once treatment and follow up are complete.
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Delivery Success Rate for SMART across multiple tumors-Phase I
timeFrame: 1 year
measure: Tumor visualization-Phase I
timeFrame: 1 Year
measure: Plan creation-Phase I
timeFrame: 1 Year
measure: Rate of Improvement in Tumor Control-Phase II
timeFrame: 1 Year
Secondary outcomes:
measure: Number of Patients with Acute Toxicity-Phase I
timeFrame: 90 Days
measure: Duration of treatment-Phase 1
timeFrame: 90 Days
measure: Number of treatment fractions-Phase1
timeFrame: 90 Days
measure: Number of Participants with long term toxicity-Phase II
timeFrame: 365 Days
measure: Disease Specific Survival Rate-Phase II
timeFrame: 365 Days
measure: Overall Survival Rate-Phase II
timeFrame: 365
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jonathan Leeman, MD
role: PRINCIPAL_INVESTIGATOR
References: