Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer
Running, not enrolling · Not applicable
Conditions studied: Pancreatic Cancer
In brief
High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity. The goal of the proposed trial is to investigative in a controlled, prospective manner the robustness of this outcome, and to track quality of life over a 5-year trial period.
Key facts
- Study ID
- NCT03621644
- Run by
- Viewray Inc.
- People needed
- 133
- Starts
- 2019-01-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2022-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable on institutional standardized criteria of unresectability or medical inoperability. Patients with and without regional adenopathy are eligible as long as lymph nodes are adjacent to primary tumor.
- Greater than or equal to 3 months of systemic chemotherapy
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 500/mcL (microliters)
- Platelets ≥ 50,000/mcL
- Hemoglobin ≥ 8.0 g/dL (deciliters)
- Total bilirubin ≤ 1.5 x IULN
- Aspartate Aminotransferase AST(SGOT) / Alanine Aminotransferase ALT(SGPT) ≤ 3.0 x Institutional Upper Limit of Normal (IULN)
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable).
You may not qualify if…
- Distant metastatic disease as assessed by staging positron emission tomography / computed tomography (PET/CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
- Carbohydrate antigen (CA19.9) > 500 U/ml.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Currently receiving any other investigational agents.
- Major surgery within 4 weeks prior to first day of treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Medical/psychological contraindication to magnetic resonance imaging (MRI).
Where it is running
- UCLA — Los Angeles, California, United States
- University of Miami — Miami, Florida, United States
- Miami Cancer Institute — Miami, Florida, United States
- Orlando Health — Orlando, Florida, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Henry Ford Health Sciences — Detroit, Michigan, United States
- Washington University — St Louis, Missouri, United States
- Dartmouth-Hitchcock — Lebanon, New Hampshire, United States
- Cornell University — New York, New York, United States
- Providence Portland Cancer Center — Portland, Oregon, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- University of Wisconisin — Madison, Wisconsin, United States
- Assuta Medical Center — Tel Aviv, Israel
Full record on ClinicalTrials.gov
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