This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.
This study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. As secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment. The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment. The treatment duration is one and a half weeks (5 fractions delivered every other weekday).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
5 fractions of SBRT (Stereotactic body radiation therapy). The target will always include the anterior-medial aspect aorta at T12-L2 (surrogate for celiac plexus). If there is adjacent tumor (e.g. pancreatic tumor that infiltrates the celiac plexus) this will be irradiated in addition. It is expected that patients will be treated with a rapid-arc IMRT (Intensity modulation radiation therapy) dose-painting technique. Details of beam arrangement and energy used will be determined on an individual basis.
Sheba Medical Center
Ramat Gan, Israel
RECRUITINGNumerical Rating Scale (NRS) pain score difference from baseline
Time frame: 3 weeks post treatment
Numerical Rating Scale (NRS) pain score difference from baseline
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Analgesic use difference from baseline in oral morphin equivalents
Average analgesic consumption will be defined using daily oral morphine equivalents in milligrams
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
QoL difference from baseline
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Safety profile of the procedure - measuring the frequency and severity of treatment side effects, mainly GI toxicities
The safety profile will focused on fatigue and expected GI (gastro-intestinal) toxicities as nausea, vomiting and diarrhea. Acute and late toxicity will be assessed using the NCI-CTCAE (common toxicity criteria for adverse events) version 4.0
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
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