Clinical trial NCT02356406: Celiac Plexus Radiosurgery for Pain Management
Official title: Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Digestive System Neoplasms
Keywords: Radiosurgery
Celiac Plexus
Pain
Quality of Life
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-02-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Patients with upper abdominal cancer (pancreatic/gastric/colon/hepato-biliary cancer) with typical retroperitoneal pain syndrome (somatic pain that radiates from the upper abdomen to the back) thought to be secondary to celiac plexus involvement, directly or indirectly, and have high level of pain despite opioids usage (NRS \>4). Patients with other cancer types metastatic to the celiac lymph nodes will also be eligible
* Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old.
* Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation and renewed at least 1 week following radiation. Following gemcitabine 2 weeks are required between final dose and commencement of radiation
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Exclusion Criteria:

* Patients under 18 years of age
* Patients who are well balanced in terms of pain control
* Patients with life expectancy \<8 weeks
* Patients with ECOG (Eastern cooperative oncology group) performance status 4
* Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy
* Special populations: pregnant women, prisoners, patients with major psychiatric illnesses
* Previous radiotherapy to upper abdomen
* Conditions associated with increased side effects to radiotherapy (IBD (inflammatory bowel disease) for example)

Primary outcomes:
measure: Numerical Rating Scale (NRS) pain score difference from baseline
timeFrame: 3 weeks post treatment
Secondary outcomes:
measure: Numerical Rating Scale (NRS) pain score difference from baseline
timeFrame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
measure: Analgesic use difference from baseline in oral morphin equivalents
timeFrame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
measure: QoL difference from baseline
timeFrame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
measure: Safety profile of the procedure - measuring the frequency and severity of treatment side effects, mainly GI toxicities
timeFrame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: David Hausner, M.D
role: PRINCIPAL_INVESTIGATOR
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