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Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer

About

Brief Summary

Radiation therapy is a common treatment for pancreatic cancer. Accurate delivery of radiation directly to the tumor, while avoiding surrounding healthy tissue, is critical to the health outcomes of the patient. This study will deliver five separate treatments or "fractions" of radiation to patients with pancreatic cancer, known as SBRT, a routine treatment for pancreatic cancer. We will be using the Viewray System, a device which has been FDA cleared and approved for this purpose. The Viewray System is unique in that it includes real-time MRI at the time of treatment. Not only does this allow radiation to be delivered more accurately, but it allows doctors to see changes from fraction to fraction and adjust the treatments quickly and easily as the anatomy changes due to these treatments. Whereas with other machines there may be times where the patient must receive additional CT scans during treatment to account for changes in the anatomy which occur between treatments, the Viewray System allows for "on the fly" adjustments with no additional CT scans and related radiation. While the system is FDA approved for the purposes indicated in this study, being a rather new device in the field, we have designed this protocol to scientifically analyze outcomes unique to this radiation delivery system.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects diagnosed with pancreatic cancer which cannot be surgically removed. For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Join this Trial

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Study Stats
Protocol No.
18-001035
Category
Oncology
Radiation Oncology
Contact
Jackie Hernandez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03621644
For detailed technical eligibility, visit ClinicalTrials.gov.