Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies

Completed · Phase 1

Conditions studied: Central Thorax Cancer, Liver Cancer, Non-Liver Abdominal Cancer

In brief

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 re-planning of treatment day by day while the participant is receiving treatment. The adaptive technique has previously been used in a different fashion to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment while the participant is still on the table is a new way of using the adaptive technique. This may allow doctors to use more radiation to treat the tumor while better protecting normal tissues. A special radiation treatment machine incorporates both an MRI scanner and radiation treatment devices so that the planning and treatment can be done using the same machine.

Key facts

Study ID

NCT02264886

Run by

Washington University School of Medicine

People needed

30

Starts

2015-01-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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