Stereotactic Body Radiotherapy for Pancreatic Cancer Pain

Overseen By Lauren Henke, MD, MSCI

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Prior upper abdomen radiotherapy, Pregnancy, Inflammatory bowel disease, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1.5 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to speed up radiation therapy for pancreatic cancer patients with severe abdominal pain. Typically, setting up this radiation treatment takes over a week. The trial investigates whether using an existing CT scan can expedite the process. The focus is on stereotactic body radiotherapy (SBRT) to reduce pain, specifically targeting the celiac plexus area. Eligible participants have pancreatic cancer causing severe pain unrelieved by medication and a recent CT scan of their abdomen. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial requires that any active cancer treatment be stopped at least 1 week before starting radiation therapy and can be resumed at least 1 week after the therapy. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What prior data suggests that this new workflow for SBRT is safe for pancreatic cancer pain?

Studies have shown that stereotactic body radiotherapy (SBRT) is a well-tolerated treatment for managing pain in patients with pancreatic cancer. Research indicates that SBRT effectively reduces pain and is generally safe. Previous trials did not report any severe side effects directly linked to the treatment. The findings suggest that patients usually handle SBRT well, with minor side effects being the most common issues, such as mild tiredness or temporary discomfort. Overall, SBRT is considered a safe option for addressing cancer-related pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the celiac plexus SBRT for pancreatic cancer pain because it offers a non-invasive approach to pain management. Unlike traditional treatments like systemic analgesics or nerve blocks, this method uses precise, high-dose radiation to target the celiac plexus, a network of nerves involved in transmitting pain signals. This targeted approach promises to minimize damage to surrounding tissues while effectively reducing pain, potentially offering quicker relief and fewer side effects compared to current options.

What evidence suggests that this new workflow for SBRT is effective for pancreatic cancer pain?

This trial will evaluate the effectiveness of stereotactic body radiotherapy (SBRT) in targeting the celiac plexus to reduce pain in people with pancreatic cancer. Studies have shown that SBRT can effectively reduce pain, with relief often beginning within a few weeks and lasting over two months. Research indicates that the best results typically appear about a month after treatment. This method targets the celiac plexus, a group of nerves in the abdomen, to help ease pain. These promising results suggest that SBRT may be a good option for managing abdominal pain caused by pancreatic cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Lauren Henke, MD, MSCI

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals

Are You a Good Fit for This Trial?

This trial is for individuals with pancreatic cancer who are experiencing abdominal pain. To participate, they must have had a CT scan at the time of their cancer diagnosis that can be used for planning treatment.

Inclusion Criteria

I am older than 18 years.

I can understand and am willing to sign the consent form.

My cancer is confirmed to be advanced and cannot be surgically removed.

Exclusion Criteria

I have a condition like inflammatory bowel disease or scleroderma that may worsen with radiation.

I have had radiation therapy to my upper abdomen.

I have taken a pregnancy test in the last 14 days and it was negative.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive stereotactic body radiotherapy (SBRT) using a simulation-free workflow to manage celiac plexus pain

1.5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Celiac plexus SBRT

Trial Overview The study is testing a new method to speed up preparation for SBRT, a type of radiation therapy for pain relief in pancreatic cancer patients. It uses existing diagnostic CT scans to eliminate the need for additional simulation and planning time.

How Is the Trial Designed?

Group I: Simulation-free treatment delivery of celiac plexus SBRT Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07117032

Simulation-Free Celiac Plexus Pain Ablation Using ... Participants who are experiencing abdominal pain due to having cancer in their pancreas may be eligible for this research study. For this type of pain, ...

2. letswinpc.org letswinpc.org/research/sbrt-pain-managment-pancreatic-cancer/

Pancreatic Cancer Pain Management a Zap Away A multinational clinical trial that tested celiac plexus radiotherapy to eliminate pain caused by pancreatic tumors has announced promising results.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204524002237

Celiac plexus radiosurgery for pain management in ... Pain appeared to be improved by stereotactic body radiotherapy; the maximum pain palliation effect was reached at approximately 1 month after treatment.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9032429/

Pain Relief after Stereotactic Radiotherapy of Pancreatic ... Pain relief was further improved in a subset of patients undergoing both SBRT and celiac plexus block in the 2–4 weeks post-treatment interval.

5. redjournal.org redjournal.org/article/S0360-3016(23)07856-2/fulltext

Prospective Phase 2 Nonrandomized PAINPANC Trial We found a rapid clinically relevant and consistently reduced pain severity within weeks, lasting for 11 weeks and longer, along with an ...

6. thelancet.com thelancet.com/cms/10.1016/S1470-2045(24)00223-7/attachment/02d722dc-ee8e-468e-9965-d9028287e697/mmc1.pdf

Supplementary appendix ... Pancreatic Cancer-Related Pain ... The safety of celiac plexus irradiation will be evaluated by the review of clinical data collected.

7. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-022-01988-6

MR-guided adaptive stereotactic body radiotherapy (SBRT) of ... SBRT has proven to be an efficacious and cost-effective [21] treatment in patients with locally advanced pancreatic cancer (LAPC) providing 1- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10873666/

Stereotactic body radiotherapy for pancreatic cancer Results showed a median OS of 14 months, along with an excellent LC rate of 85 % at one year. The efficacy of combining immunotherapy with radiation in the ...