Celiac Plexus Radiosurgery for Pain Management

February 5, 2015 updated by: David Hausner M.D, Sheba Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: David Hausner, M.D, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

February 1, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

February 6, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-1630-DH-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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