Advanced CancerNCT03323489
Celiac Plexus Radio-Surgery for Pain Management
A study testing Celiac Plexus Radiosurgery in people with Advanced Cancer and Pancreas Cancer, run by Dr. Yaacov Lawrence at 7 sites in 4 countries.
Trial summary
Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses of painkiller required often induce side effects, whereas nerve block procedures (where a needle is deeply inserted into the back)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Pancreas Cancer, Pain
- What is being tested?
- Celiac Plexus Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Jan 2018to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A section 24).
- Patients must have a malignancy that is metastatic or unresectable (for surgical or medical reasons).
- Typical retroperitoneal pain syndrome (pain that radiates from the lower back to the upper abdomen, belt like distribution).
- Uncontrolled pain at recruitment, defined as >=5 on 11 point BPI scale despite analgesic use.
- Anatomical involvement of the celiac plexus, as defined by at least one of the following:
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- Any Pancreatic cancer
- Any other cancer that on imaging demonstrates either: gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels, that typically implies tumor engulfment.
- Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old. The CT simulation performed as part of the protocol will be considered sufficient.
- Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 6 days prior to radiation and renewed at least 6 days following radiation. For trastuzumab emtansine a 14 break prior to, and a 6 day break post-therapy is required. Hormonal treatments (e.g. tamoxifen, androgen ablation, androgen antagonists, aromatase inhibitors), and bone-strengthening agents (e.g. bisphosphonates, anti-RANKL antibody denosumab) may be continued during the radiation treatment, and do not need to be interrupted.
- Willingness to attend 3- and 6- week follow-up visits, and participate in telephone follow-up thereafter.
- Radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Before patient registration, written informed consent must be provided.
Who cannot join
- Patients under 18 years of age
- Patients who are well balanced in terms of pain control
- Patients with life expectancy <8 weeks as defined by the primary oncologist.
- Known serum albumin <2.4 (does not need to be especially tested if unknown).*
- Known lymphopenia defined as <12% of white blood count (does not need to be especially tested if unknown).*
- Altered mental status (defined as change in brain function from baseline including confusion, drowsiness, delirium, dementia or coma)*
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- Leptomeningeal spread*
- Current or previous spinal cord compression*
- Significant comorbidities (this is left to physicians' discretion. Guidance provided below section 8.4. As an example, patients with metastatic cancer, in the context of combined impaired renal and hepatic function are expected to have a poor survival)*
- Patients with ECOG Performance status 3 or 4*
- Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy.
- Previous radiotherapy to upper abdomen.
- Conditions associated with increased side effects to radiotherapy (Inflammatory bowel disease, scleroderma for example).
- Patients who have not recovered from the acute adverse events due to prior anti-cancer therapy (however peripheral neuropathy and other chronic side effects of anti-cancer therapy are not exclusion criteria).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Special populations: pregnant women, prisoners, patients with major psychiatric illnesses.
- Unwilling or unable to attend 3-week and 6-week post treatment assessments.
- these factors are all associated with a very poor prognosis. 40 ------ Nb There are criteria that exclude patients from performing the six-minute walk test (see section 29). These patients may nonetheless participate in the protocol and undergo celiac axis radiosurgery.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Israel3 sites
Sheba Medical Center
Ramat Gan
Assuta Hospital in Ramat HaHayal
Tel Aviv
Tel Aviv Sourasky Medical Center
Tel Aviv
United States2 sites
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
The Mount Sinai Hospital
New York, New York, 10029-6574
Portugal1 site
Instituto Português de Oncologia do Porto Francisco Gentil
Porto, 4200-072
About this study
Official title: Celiac Plexus Radio-Surgery for Pain Management in Advanced Cancer Patients - a Phase II Trial
Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses of painkiller required often induce side effects, whereas nerve block procedures (where a needle is deeply inserted into the back) are both invasive and of limited benefit.
This clinical trial investigates a unique novel approach in which high-dose radiation (radiosurgery) is focused on the offending nerve bundle (the celiac plexus) in the posterior abdomen. Preliminary results from a single institution pilot trial are very promising: pain relief is substantial and side effects minimal. In this multi-center clinical trial, patients will be accrued and receive treatment at several international locations.
Read more
Main aim of the study:
Establish the safety and efficacy of the treatment in the multi-center setting.
This trial will bring pain relief to cancer sufferers and improve current acceptable standard of care. The trial resonates with the Gateway mission of promoting new treatments that directly benefit people living with cancer, enhancing their wellbeing, and consequently decreasing the fear associated with a cancer diagnosis.
Read the detailed description
Severe lower back pain radiating anteriorly in a belt-like distribution is characteristic of pancreatic cancer. The pain is thought related to involvement of the celiac nerve plexus, located behind the pancreas; due to either macroscopic compression or microscopic perineural invasion.
Contemporary approaches (narcotic analgesics, celiac nerve blocks and systemic chemotherapy) each have drawbacks, and as a consequence many patients suffer from severe pain. We hypothesized that ablative radiosurgery (high dose, precise X-ray treatment) focused on the celiac plexus would succeed in palliating these patients, possibly by interrupting pain transmission. It is important to emphasize that bringing pain relief to cancer patients is not only humane, but also associated with improved mood, quality of life and possibly improved survival. Our preliminary results suggest that the treatment is both effective and well tolerated; furthermore it appears that the patients tolerate subsequent cytotoxic treatments better. We will perform a prospective phase II multicenter clinical trial to test our hypothesis Compared to the small pilot trial the follow-up trial will: 1) Enroll a larger number of patients (n=100). 2) Be performed across a number of institutions, in both the Middle East and the United States. 3) Include improved measures of quality of life and functional capacity. 'Caregiver burden' and 'Patient hope' will also be assessed. 4) Incorporate exploratory translational endpoints relating to immune activation.
Target population Adult patients with severe, poorly controlled lower back/abdominal pain (intensity at least 5/10 on the Numeric Pain Rating Scale) thought to originate in the celiac plexus (generally, but not exclusively, from pancreatic cancer). Patients with a poor prognosis, and those with previous radiation to the upper abdomen will be excluded. Systemic therapies will need to be stopped several days prior to, and following, treatment.
- Conditions
- Advanced Cancer, Pancreas Cancer, Pain
- Being tested
- Celiac Plexus Radiosurgery
- Keywords
- celiac, radiosurgery, sbrt, radiotherapy, pain
- Medical subject headings
- Pancreatic Neoplasms, Pain, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celiac Plexus RadiosurgeryRadiation
patients will receive a single radiation treatment of 25 Gy directed towards the celiac surgery, and at the physician's discretion also abutting tumor
| Study group | Role | What they receive |
|---|---|---|
| celiac radiosurgery, single fraction | Experimental | Celiac Plexus Radiosurgery Receives: Radiation: Celiac Plexus Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain level from baseline - as measured using BPI
complete or partial pain response as assessed with the BPI scale
Measured: three weeks
Secondary outcomes (5)
Average Pain Level
Patient reported average pain as assessed with the BPI scale (0 to 10)
Measured: 3 weeks and 6 weeks
Opioid use
daily opioid usage
Measured: 3 weeks and 6 weeks
Quality of Life as measured using FACT-Hep questionnaire
as measured using FACT-Hep scale
Measured: 3 weeks and 6 weeks
six minute walk
assess how far patient can walk in 6 minutes, a measure of functionality
Measured: 3 weeks and 6 weeks
hand grip strength
measure with hand dynamometer, a measure of functionality
Measured: 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Jan 2018
- Primary completion30 Jan 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all of the patients will be treated.
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Yaacov Lawrence
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Yaacov Lawrence, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323489
- Sponsor's protocol ID
- SHEBA-17-4292-YL-CTIL
- Status last verified
- May 2022
- First submitted
- 3 Oct 2017
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lawrence YR, Miszczyk M, Dawson LA, Diaz Pardo DA, Aguiar A, Limon D, Pfeffer RM, Buckstein M, Barry AS, Meron T, Dicker AP, Wydmanski J, Zimmermann C, Margalit O, Hausner D, Morag O, Golan T, Jacobson G, Dubinski S, Stanescu T, Fluss R, Freedman LS, Ben-Ayun M, Symon Z. Celiac plexus radiosurgery for pain management in advanced cancer: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Aug;25(8):1070-1079. doi: 10.1016/S1470-2045(24)00223-7. Epub 2024 Jul 16.
PubMed 39029483Jacobson G, Fluss R, Dany-BenShushan A, Golan T, Meron T, Zimmermann C, Dawson LA, Barry A, Miszczyk M, Buckstein M, Diaz Pardo D, Aguiar A, Hammer L, Dicker AP, Ben-Ailan M, Morag O, Hausner D, Symon Z, Lawrence YR. Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial. BMJ Open. 2022 Mar 24;12(3):e050169. doi: 10.1136/bmjopen-2021-050169.
PubMed 35332036
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Plexus Radio-Surgery for Pain Management in Advanced Cancer Patients - a Phase II Trial
- ClinicalTrials.gov ID
- NCT03323489
- Acronym / sponsor ID
- SHEBA-17-4292-YL-CTIL
- Conditions
- Advanced Cancer, Pancreas Cancer, Pain
- Keywords
- celiac, radiosurgery, sbrt, radiotherapy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Dr. Yaacov LawrenceOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses of painkiller required often induce side effects, whereas nerve block procedures (where a needle is deeply inserted into the back) are both invasive and of limited benefit.
This clinical trial investigates a unique novel approach in which high-dose radiation (radiosurgery) is focused on the offending nerve bundle (the celiac plexus) in the posterior abdomen. Preliminary results from a single institution pilot trial are very promising: pain relief is substantial and side effects minimal. In this multi-center clinical trial, patients will be accrued and receive treatment at several international locations.
Main aim of the study:
Establish the safety and efficacy of the treatment in the multi-center setting.
This trial will bring pain relief to cancer sufferers and improve current acceptable standard of care. The trial resonates with the Gateway mission of promoting new treatments that directly benefit people living with cancer, enhancing their wellbeing, and consequently decreasing the fear associated with a cancer diagnosis.
Detailed description
Severe lower back pain radiating anteriorly in a belt-like distribution is characteristic of pancreatic cancer. The pain is thought related to involvement of the celiac nerve plexus, located behind the pancreas; due to either macroscopic compression or microscopic perineural invasion.
Contemporary approaches (narcotic analgesics, celiac nerve blocks and systemic chemotherapy) each have drawbacks, and as a consequence many patients suffer from severe pain. We hypothesized that ablative radiosurgery (high dose, precise X-ray treatment) focused on the celiac plexus would succeed in palliating these patients, possibly by interrupting pain transmission. It is important to emphasize that bringing pain relief to cancer patients is not only humane, but also associated with improved mood, quality of life and possibly improved survival. Our preliminary results suggest that the treatment is both effective and well tolerated; furthermore it appears that the patients tolerate subsequent cytotoxic treatments better. We will perform a prospective phase II multicenter clinical trial to test our hypothesis Compared to the small pilot trial the follow-up trial will: 1) Enroll a larger number of patients (n=100). 2) Be performed across a number of institutions, in both the Middle East and the United States. 3) Include improved measures of quality of life and functional capacity. 'Caregiver burden' and 'Patient hope' will also be assessed. 4) Incorporate exploratory translational endpoints relating to immune activation.
Target population Adult patients with severe, poorly controlled lower back/abdominal pain (intensity at least 5/10 on the Numeric Pain Rating Scale) thought to originate in the celiac plexus (generally, but not exclusively, from pancreatic cancer). Patients with a poor prognosis, and those with previous radiation to the upper abdomen will be excluded. Systemic therapies will need to be stopped several days prior to, and following, treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all of the patients will be treated.
| Arm | Type | Receives |
|---|---|---|
| celiac radiosurgery, single fraction | Experimental | Radiation: Celiac Plexus RadiosurgeryCeliac Plexus Radiosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A section 24).
- Patients must have a malignancy that is metastatic or unresectable (for surgical or medical reasons).
- Typical retroperitoneal pain syndrome (pain that radiates from the lower back to the upper abdomen, belt like distribution).
- Uncontrolled pain at recruitment, defined as >=5 on 11 point BPI scale despite analgesic use.
Key exclusion criteria (18 listed)
- Patients under 18 years of age
- Patients who are well balanced in terms of pain control
- Patients with life expectancy <8 weeks as defined by the primary oncologist.
- Known serum albumin <2.4 (does not need to be especially tested if unknown).*
- Known lymphopenia defined as <12% of white blood count (does not need to be especially tested if unknown).*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celiac Plexus Radiosurgerypatients will receive a single radiation treatment of 25 Gy directed towards the celiac surgery, and at the physician's discretion also abutting tumor | Radiation | celiac radiosurgery, single fraction |
Primary outcome
Change in Pain level from baseline - as measured using BPI
Time frame: three weeks
complete or partial pain response as assessed with the BPI scale
5 secondary outcomes
Average Pain Level
Time frame: 3 weeks and 6 weeks
Opioid use
Time frame: 3 weeks and 6 weeks
Quality of Life as measured using FACT-Hep questionnaire
Time frame: 3 weeks and 6 weeks
six minute walk
Time frame: 3 weeks and 6 weeks
hand grip strength
Time frame: 3 weeks and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 39029483Lawrence YR, Miszczyk M, Dawson LA, Diaz Pardo DA, Aguiar A, Limon D, Pfeffer RM, Buckstein M, Barry AS, Meron T, Dicker AP, Wydmanski J, Zimmermann C, Margalit O, Hausner D, Morag O, Golan T, Jacobson G, Dubinski S, Stanescu T, Fluss R, Freedman LS, Ben-Ayun M, Symon Z. Celiac plexus radiosurgery for pain management in advanced cancer: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Aug;25(8):1070-1079. doi: 10.1016/S1470-2045(24)00223-7. Epub 2024 Jul 16.
- Derived from this study: PubMed 35332036Jacobson G, Fluss R, Dany-BenShushan A, Golan T, Meron T, Zimmermann C, Dawson LA, Barry A, Miszczyk M, Buckstein M, Diaz Pardo D, Aguiar A, Hammer L, Dicker AP, Ben-Ailan M, Morag O, Hausner D, Symon Z, Lawrence YR. Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial. BMJ Open. 2022 Mar 24;12(3):e050169. doi: 10.1136/bmjopen-2021-050169.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celiac Plexus Radiosurgery in people with Advanced Cancer and Pancreas Cancer, run by Dr. Yaacov Lawrence at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel, United States, Canada, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain level from baseline - as measured using BPI (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323489, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.