Status:
COMPLETED
Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
Lead Sponsor:
Washington University School of Medicine
Conditions:
Central Thorax Cancer
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is evaluate whether it's feasible to give radiation therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy involves the adjustment or ...
Detailed Description
In this trial, the feasibility of delivering online, adaptive MRI-guided stereotactic body radiation therapy for oligometastatic disease using a novel, integrated Co-60-MRI machine will be evaluated. ...
Eligibility Criteria
Inclusion
- Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven primary disease histology of solid tumor categorization with the exception of small cell cancers.
- Must be deemed medically fit for SBRT to the liver or lung by the treating physician.
- At least 18 years of age.
- Karnofsky performance status \> 60 (see Appendix A)
- Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion
- Primary disease of hematologic origin, lymphoma, or small cell cancer.
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT.
- Widespread progressive disease, i.e., more than 3 sites of progressive disease (more than 3 sites of disease are permitted provided there are no more than 3 sites of progressive disease).
- Currently receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.
- Medical contraindication to undergoing MR imaging.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02264886
Start Date
January 1 2015
End Date
December 1 2016
Last Update
December 9 2016
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110