Celiac Plexus Radiosurgery for Pain Management

Study Overview
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Brief Summary
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This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.

Detailed Description
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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).

Official Title
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Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial

Conditions
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Digestive System Neoplasms

Intervention / Treatment
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* Radiation: Celiac Plexus Radiosurgery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celiac Plexus Radiosurgery<br>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 | Radiation: Celiac Plexus Radiosurgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) pain score difference from baseline |  | 3 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) pain score difference from baseline |  | 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 | 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment | 
| QoL difference from baseline |  | 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 | 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiosurgery, Celiac Plexus, Pain, Quality of Life