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Celiac Plexus Radiosurgery for Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02356406
Recruitment Status : Unknown
Verified February 2015 by David Hausner M.D, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : February 5, 2015
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
David Hausner M.D, Sheba Medical Center

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

Condition or disease Intervention/treatment Phase
Digestive System Neoplasms Radiation: Celiac Plexus Radiosurgery Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Celiac Plexus Radiosurgery

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

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.


Outcome Measures
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Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) pain score difference from baseline [ Time Frame: 3 weeks post treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Analgesic use difference from baseline in oral morphin equivalents [ Time Frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment ]
    Average analgesic consumption will be defined using daily oral morphine equivalents in milligrams

  3. 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 ]
  4. Safety profile of the procedure - measuring the frequency and severity of treatment side effects, mainly GI toxicities [ Time Frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356406


Contacts
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Contact: David Hausner, M.D 972-35302542 david.hausner@sheba.health.gov.il
Contact: Yaacov R Lawrence, MBBS MA MRCP 972-35302290 Yaacov.Lawrence@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: David Hausner, M.D    972-35302542    David.Hausner@sheba.health.gov.il   
Contact: Yaacov R Lawrence, MBBS MA MRCP    972-35302290    Yaacov.Lawrence@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: David Hausner, M.D Sheba Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: David Hausner M.D, palliative care physician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02356406    
Other Study ID Numbers: SHEBA-14-1630-DH-CTIL
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015
Keywords provided by David Hausner M.D, Sheba Medical Center:
Radiosurgery
Celiac Plexus
Pain
Quality of Life
Additional relevant MeSH terms:
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Digestive System Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
 Digestive System Diseases
Neoplasms by Site
Neoplasms