Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Prostatic Neoplasms

Carcinoma, Renal Cell

Neoplasm Metastasis

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Kidney Neoplasms

Neoplasms, Second Primary

Brain Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Adenocarcinoma

Pancreatic Cancer

Renal Cell Carcinoma

Malignant Mesothelioma

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Epinephrine

Liver Extracts

Pancrelipase

Racepinephrine

Epinephryl borate

Pancreatin

SMART will be administered per each individual disease site standards

Radiation will be delivered on an MR-guided Linear Accelerator

MR-guided Linac

Jonathan Leeman, MD

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.

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.

Stereotactic Magnetic Resonance Guided Radiation Therapy

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Dr. Jonathan Leeman (jonathane_leeman@dfci.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Enrolling patients and delivering SMART on the MR Linac

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

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

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

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

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

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

Dana-Farber Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Stereotactic Magnetic Resonance Guided Radiation Therapy	NCT04115254	Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metasta... Prostate Cancer Liver Metastase... Oligoprogressiv... Metachronous No... Synchronous Nod... Mesothelioma Spine Metastase... Brain Metastase... Borderline Rese...	MR-guided Linac	18 Years -	Dana-Farber Cancer Institute
Stereotactic Magnetic Resonance Guided Radiation Therapy	NCT04115254	Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metasta... Prostate Cancer Liver Metastase... Oligoprogressiv... Metachronous No... Synchronous Nod... Mesothelioma Spine Metastase... Brain Metastase... Borderline Rese...	MR-guided Linac	18 Years -	Dana-Farber Cancer Institute

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