OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
The purpose of this trial is to identify a safe maximum tolerated dose level for MRI-guided Stereotactic Body Radiation Therapy (SBRT) treatment of bowel and liver metastases, respectively.
Eligible participants will be on study for up to 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of histologically confirmed or clinically suspected metastatic cancer to the liver.
Participant must be a candidate for SBRT to at least one intrahepatic lesion but no more than 6 intrahepatic lesions.
Participant must be a candidate for treatment on the ViewRay treatment unit. Must be screened to rule out implants and devices that are not MRI compatible.
Be willing and able to provide written informed consent.
Disqualifiers
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the initiation of SBRT.
History of a second invasive cancer in the last 3 years (except for appropriately treated low-risk prostate cancer, treated non-melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast appropriately treated in situ/early stage cervical/endometrial cancer.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Trial design
Design model
Single group
Treatments tested in this trial
SBRT
RadiationParticipants will receive 5 fractions of radiation, which will be delivered 2-3 times per week. SBRT should be complete in a 1.5 to 2 week time frame. There should be a minimum of 12 hours between treatments.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: MRI-Guided SBRT Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Acute Dose Limiting Toxicity (DLT)
Dose limiting toxicity (DLT) will be defined as grade 3 or greater\* non-hematologic toxicity attributable to radiation therapy, and occurring within 4 weeks after the completion of SBRT. \*With the exception of liver function tests, which are allowed up to and including grade 3
Time frame
Up to 4 weeksSecondary outcomes
1
Progression Free Survival (PFS)
Progression-free survival (PFS) will be defined as the difference (in months) between the date of study enrollment and the date of disease progression or death due to any cause
Time frame
Up to 5 years2
Overall Survival (OS)
Overall survival (OS) will be defined as the difference (in months) between the date of study enrollment to the date death due to any cause.
Time frame
Up to 5 years3
Local Control Rates
Point estimates along with the exact 95% confidence interval will be computed for the local control rates
Time frame
up to 2 years4
Change in Quality of Life (QoL)
QoL will be assessed on a 5 item questionnaire using a 4-point Likert scale, where 4 = Not at all and 1 = Constant. Scores range from 5-20 where higher scores indicate better quality of life.
Time frame
Baseline, 2 months (1 month post treatment follow-up)Sponsors and contacts
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Source ClinicalTrials.gov