The objectives of this study are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and to determine the maximum tolerated dose (MTD) while evaluating treatment delivery, safety, and efficacy utilizing a pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver lesions.
Primary endpoints of this protocol are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and then to determine the maximum tolerated dose (MTD) of navigated percutaneous interstitial HDR brachytherapy for liver lesions. Secondary endpoints include assessment of toxicity and oncologic outcome (primarily local control at the treated site) and exploratory endpoints will be supported by advanced imaging studies at the time of the treatment procedure. The 25 Gy starting dose was chosen as it has been shown to be effective at controlling tumor, albeit with limited followup. The promising outcomes noted at that dose are predicated on actually delivering that dose, hence the feasibility endpoint for meeting the goal dose delivery. While the other primary endpoint will be toxicity so as to avoid exceeding the MTD, this trial will treat more patients at each level to better characterize both toxicity and efficacy within a dose level (the therapeutic window). The investigators will attempt to escalate to levels that modeling would predict to have durable local control approaching 100%.55 Dose escalation levels of 5 Gy were chosen to mirror other studies performed at this institution with SBRT
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions
UT Southwestern Medical Center
Dallas, Texas, United States
dosimetric coverage of liver lesions
Verify feasibility of HDR brachytherapy treatment and workflow for liver lesions using catheters placed under image-guided navigational techniques, to provide dosimetric coverage of liver lesions such that: 1. Minimum CTV peripheral dose ≥ 25 Gy (D100 ≥ 25 Gy) 2. 67% or 700 cc Liver \< 5 Gy 3. Esophagus, stomach, bowel, or duodenum \< 15 Gy to 1cc, \< 12 Gy to 5cc, \< 9 Gy to 10cc, and 85 Gy in BED(2Gy) equivalent including current and prior treatment to 1cc 4. Spinal cord/cauda equina \< 8 Gy to 1 cc, or 75 Gy in 2 Gy fractions BED(2Gy) equivalent including current and prior treatment 5. Kidney \< 11 Gy, 200 cc \< 8.4 Gy 4\. Spinal cord/cauda equina \< 8 Gy to 1 cc, or 75 Gy in 2 Gy fractions BED(2Gy) equivalent including current and prior treatment 5. Kidney \< 11 Gy, 200 cc \< 8.4 Gy Verify feasibility of HDR brachytherapy treatment and workflow for liver lesions using catheters placed under image-guided navigational techniques
Time frame: 1 day
maximum tolerated dose
Determine the maximum tolerated dose (MTD) for percutaneous image-guided navigated high dose rate brachytherapy for liver lesions. 1. Initial dose level; as above, minimum CTV peripheral dose ≥ 25 Gy 2. Dose level 2: minimum CTV peripheral dose ≥ 30 Gy 3. Dose level 3: minimum CTV peripheral dose ≥ 35 Gy
Time frame: 90 days
severe toxicity
Demonstrate safety of HDR brachytherapy for lesions of the liver, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 Clavien-Dindo scale surgical complication score within 30 days of treatment or by NCI CTCAE v 4.0 toxicity after 30 days that is at least possibly related to treatment
Time frame: 30 days
local control
Assess patients for duration of local control at the treatment site, as well as other oncologic outcomes including progression-free and overall survival.
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Time frame: 2 years