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Celiac Plexus Radiosurgery for Pain Management

Primary Purpose

Digestive System Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Celiac Plexus Radiosurgery

About this trial

This is an interventional supportive care trial for Digestive System Neoplasms focused on measuring Radiosurgery, Celiac Plexus, Pain, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celiac Plexus Radiosurgery

Arm Description

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

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS) pain score difference from baseline

Secondary Outcome Measures

Numerical Rating Scale (NRS) pain score difference from baseline

Analgesic use difference from baseline in oral morphin equivalents

Average analgesic consumption will be defined using daily oral morphine equivalents in milligrams

QoL difference from baseline

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

Full Information

NCT ID

NCT02356406

First Posted

January 21, 2015

Last Updated

February 5, 2015

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02356406

Brief Title

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

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Digestive System Neoplasms

Keywords

Radiosurgery, Celiac Plexus, Pain, Quality of Life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Celiac Plexus Radiosurgery

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Celiac Plexus Radiosurgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

Numerical Rating Scale (NRS) pain score difference from baseline

Time Frame

3 weeks post treatment

Secondary Outcome Measure Information:

Title

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

Title

Analgesic use difference from baseline in oral morphin equivalents

Description

Average analgesic consumption will be defined using daily oral morphine equivalents in milligrams

Time Frame

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

Title

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

Title

Safety profile of the procedure - measuring the frequency and severity of treatment side effects, mainly GI toxicities

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Hausner, M.D

Phone

972-35302542

david.hausner@sheba.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Yaacov R Lawrence, MBBS MA MRCP

Phone

972-35302290

Yaacov.Lawrence@sheba.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Hausner, M.D

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Ramat-Gan

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Hausner, M.D

Phone

972-35302542

David.Hausner@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Yaacov R Lawrence, MBBS MA MRCP

Phone

972-35302290

Yaacov.Lawrence@sheba.health.gov.il

12. IPD Sharing Statement

Citations:

PubMed Identifier

12776048

Citation

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.

Results Reference

background

PubMed Identifier

21997984

Citation

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.

Results Reference

background

PubMed Identifier

10561305

Citation

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.

Results Reference

background

PubMed Identifier

14996778

Citation

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.

Results Reference

background

PubMed Identifier

23255971

Citation

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.

Results Reference

background

PubMed Identifier

20839073

Citation

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.

Results Reference

background

PubMed Identifier

20308870

Citation

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.

Results Reference

background

PubMed Identifier

22250589

Citation

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.

Results Reference

background

PubMed Identifier

23562768

Citation

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.

Results Reference

background

PubMed Identifier

11690728

Citation

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.

Results Reference

background

PubMed Identifier

18055266

Citation

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.

Results Reference

background

PubMed Identifier

21429019

Citation

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.

Results Reference

background

PubMed Identifier

35257800

Citation

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.

Results Reference

derived

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Celiac Plexus Radiosurgery for Pain Management

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