NCT02356406

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

January 21, 2015

Last Update Submit

February 5, 2015

Conditions

Digestive System Neoplasms

Keywords

RadiosurgeryCeliac PlexusPainQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (NRS) pain score difference from baseline

    3 weeks post treatment

Secondary Outcomes (4)

  • 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

    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

    6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment

Study Arms (1)

Celiac Plexus Radiosurgery

EXPERIMENTAL

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

Interventions

Celiac Plexus RadiosurgeryRADIATION

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.

Celiac Plexus Radiosurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (13)

  • Levy MJ, Wiersema MJ. EUS-guided celiac plexus neurolysis and celiac plexus block. Gastrointest Endosc. 2003 Jun;57(7):923-30. doi: 10.1016/s0016-5107(03)70036-4. No abstract available.

    PMID: 12776048BACKGROUND

  • Kambadakone A, Thabet A, Gervais DA, Mueller PR, Arellano RS. CT-guided celiac plexus neurolysis: a review of anatomy, indications, technique, and tips for successful treatment. Radiographics. 2011 Oct;31(6):1599-621. doi: 10.1148/rg.316115526.

    PMID: 21997984BACKGROUND

  • Zhu Z, Friess H, diMola FF, Zimmermann A, Graber HU, Korc M, Buchler MW. Nerve growth factor expression correlates with perineural invasion and pain in human pancreatic cancer. J Clin Oncol. 1999 Aug;17(8):2419-28. doi: 10.1200/JCO.1999.17.8.2419.

    PMID: 10561305BACKGROUND

  • Wong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO. Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA. 2004 Mar 3;291(9):1092-9. doi: 10.1001/jama.291.9.1092.

    PMID: 14996778BACKGROUND

  • Smigielski J, Piskorz L, Wawrzycki M, Kutwin L, Misiak P, Brocki M. Assessment of quality of life in patients with non-operated pancreatic cancer after videothoracoscopic splanchnicectomy. Wideochir Inne Tech Maloinwazyjne. 2011 Sep;6(3):132-7. doi: 10.5114/wiitm.2011.24690. Epub 2011 Sep 30.

    PMID: 23255971BACKGROUND

  • Didolkar MS, Coleman CW, Brenner MJ, Chu KU, Olexa N, Stanwyck E, Yu A, Neerchal N, Rabinowitz S. Image-guided stereotactic radiosurgery for locally advanced pancreatic adenocarcinoma results of first 85 patients. J Gastrointest Surg. 2010 Oct;14(10):1547-59. doi: 10.1007/s11605-010-1323-7. Epub 2010 Sep 14.

    PMID: 20839073BACKGROUND

  • Rwigema JC, Parikh SD, Heron DE, Howell M, Zeh H, Moser AJ, Bahary N, Quinn A, Burton SA. Stereotactic body radiotherapy in the treatment of advanced adenocarcinoma of the pancreas. Am J Clin Oncol. 2011 Feb;34(1):63-9. doi: 10.1097/COC.0b013e3181d270b4.

    PMID: 20308870BACKGROUND

  • Macchia G, Morganti AG, Cilla S, Ippolito E, Massaccesi M, Picardi V, Mattiucci GC, Bonomo P, Tambaro R, Pacelli F, Piermattei A, De Spirito M, Valentini V, Cellini N, Deodato F. Quality of life and toxicity of stereotactic radiotherapy in pancreatic tumors: a case series. Cancer Invest. 2012 Feb;30(2):149-55. doi: 10.3109/07357907.2011.640649.

    PMID: 22250589BACKGROUND

  • Chuong MD, Springett GM, Freilich JM, Park CK, Weber JM, Mellon EA, Hodul PJ, Malafa MP, Meredith KL, Hoffe SE, Shridhar R. Stereotactic body radiation therapy for locally advanced and borderline resectable pancreatic cancer is effective and well tolerated. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):516-22. doi: 10.1016/j.ijrobp.2013.02.022. Epub 2013 Apr 5.

    PMID: 23562768BACKGROUND

  • Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

    PMID: 11690728BACKGROUND

  • Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.

    PMID: 18055266BACKGROUND

  • Iwata K, Yasuda I, Enya M, Mukai T, Nakashima M, Doi S, Iwashita T, Tomita E, Moriwaki H. Predictive factors for pain relief after endoscopic ultrasound-guided celiac plexus neurolysis. Dig Endosc. 2011 Apr;23(2):140-5. doi: 10.1111/j.1443-1661.2010.01046.x. Epub 2010 Dec 7.

    PMID: 21429019BACKGROUND

  • Hammer L, Hausner D, Ben-Ayun M, Shacham-Shmueli E, Morag O, Margalit O, Boursi B, Yarom N, Jacobson G, Katzman T, Abrams R, Dicker A, Golan T, Symon Z, Lawrence YR. Single-Fraction Celiac Plexus Radiosurgery: A Preliminary Proof-of-Concept Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. 2022 Jul 1;113(3):588-593. doi: 10.1016/j.ijrobp.2022.02.038. Epub 2022 Mar 4.

    PMID: 35257800DERIVED

MeSH Terms

Conditions

Digestive System NeoplasmsPain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Hausner, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Hausner, M.D

CONTACT

972-35302542david.hausner@sheba.health.gov.il

Yaacov R Lawrence, MBBS MA MRCP

CONTACT

972-35302290Yaacov.Lawrence@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
palliative care physician

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 5, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

IL(1)