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

ENROLLING
Protocol # :
19-353
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
Phase
I/II
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Other Hematopoietic
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Lymphoid Leukemia
Myeloid and Monocytic Leukemia
Leukemia, other
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Leeman, Jonathan
Site Research Nurses
Mann, Eileen, Marie
Spicer, Beverly, A.

Trial Description

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 Requirements

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

19-353