A clinical trial of radiosurgery to the celiac plexus to overcome pain

An international study to assess the efficacy of a new technique to reduce pain and improve quality of life amongst pancreatic cancer patients suffering from pain.

Details of the study

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.

This trial aims to 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.

Dr Yaacov Lawrence, principal investigator:

Dr Yaacov Lawrence MA MBBS MRCP graduated from Cambridge University and University College Hospital, London. He is board certified in Internal Medicine and Radiation Oncology.

Between 2007-2010 he was a Fellow and subsequently Attending Physician at Thomas Jefferson University, Philadelphia.

In 2009 he was awarded an ASCO Young Investigator Award. Currently Dr Lawrence leads the Gastro-intestinal program within the Department of Radiation Oncology, Sheba Medical Center and heads the Research Division within the department.

He is a Senior Lecturer at Tel Aviv University. He has received funding from the Israel Cancer Association, the Israel Science Foundation, Israel Cancer Research Fund, NATO, European Union FP7 program, NATO, the Rosetree’s foundation, Pharmaceutical companies, and Gateway for Cancer Research.

Frequently asked questions
regarding participation in the trial

Why am I in pain?

Just in front of the spinal cord in the mid-to-lower back, between the kidneys, behind the pancreas, is an important structure called the celiac plexus where many nerves come together (think of it as a junction on a highway). When tumors press, or invade into this structure people feel intense pain.

Who Can Participate in this Trial

Cancer patients who suffer from severe upper abdominal (stomach) or lower back pain, despite painkillers. This treatment is not suitable for everyone with uncontrolled cancer pain.

Only patients whose physician believes that their pain is the result of pressure/invasion of the celiac plexus nerve will be treated, this includes all patients with pancreatic cancer, and any other cancer invading this area.

In addition, patients will need to be well enough to visit the hospital and undergo the follow up visits.

What is the purpose of this treatment?

In this treatment X rays will be directed precisely onto the celiac plexus with the aim of improving your pain. Tumor pressing onto the nerves may also be targeted. The aim of the treatment is that you feel better. We do not expect that the treatment will shrink your tumor.

How many times will I visit the hospital?

You will need to visit the hospital a number of times:

  • Initial meeting with physician.
  • Simulation (a special type of CT scan used to plan radiation treatment).
  • The treatment itself (one visit).
  • Three week follow up appointment. (maybe replaced by a phone call).
  • Six week follow up appointment. (maybe replaced by a phone call).
What about my painkillers?

The purpose of this trial is to reduce the amount of pain you have. During the trial you should continue taking your regular pain medications, however if the pain improves you should ask your physician about reducing the dose of painkillers taken.

What about my chemotherapy?

The purpose of chemotherapy, and other types of anti-cancer drugs, is to prevent tumor growth. We do not yet know if it is safe to combine these drugs with radiation. Therefore we request that patients not receive chemotherapy, or other types of anti-cancer drugs, 6 days prior to, or following, radiation treatment.

What is a clinical trial?

Clinical trials are research studies that explore whether a new medical treatment is safe and effective for humans. These studies also assess which approaches work best for certain groups of people. Clinical trials produce the best data available for health care decision making.

The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

How does radiation therapy work?

Radiation therapy uses high-energy X-ray radiation to shrink tumors and kill cancer cells by damaging their DNA. The  radiation will be delivered by a machine outside the body (see picture). About half of all cancer patients receive some type of radiation therapy sometime during the course of their treatment.

What will happen if I take part in this research study?

Before receiving radiosurgery treatment, you will have a treatment planning session (simulation).  You will lie in a specific position, possibly within a frame device, while doctors check the location of the celiac plexus  and plan your treatment. A computer-assisted treatment will be designed and a radiation dose will be worked out for you. The session will last about 60-90 minutes. 

 

Within 28 days following your treatment planning session, you will receive one high dose radiation treatment. This treatment will last about 60 minutes. This is the entire treatment.

 

Your doctor may give you pain medication before the planning session and/or the radiation treatment to decrease any discomfort you may have due to the time spent in each session. Your doctor also may give you medicine to decrease anxiety and prevent any nausea that you may feel.

What are the expected side effects?

Most patients have had minimal side effects from this treatment, but as a new treatment we are still learning and we do not fully understand all the risks.

  • Possible side effects:
  • Nausea / vomiting especially within 48 hours of treatment
  • Slight worsening of pain for first five to ten days following treatment
  • Loose stools / diarrhea

Many of these side effects can be prevented / effectively treated. If you enroll on the trial, your physician will discuss this with you.

How many people will take part in the study?

About 120 people will participate in this study, they will be accrued at different hospitals across the world.  

What are my other options?

Other options for controlling your pain may include increasing the dose of pain-medication, performing a celiac-nerve block (when chemicals are injected into the nerves to destroy them), receiving chemotherapy or receiving alternative treatments such as acupuncture. You should discuss these options with your physician.

Who can I discuss my concerns with?

You may want to discuss whether to participate in this trial with your close relatives, friends, family doctor and medical team. Support groups of people with similar diseases are often a good source of medical advice.

Who is running the trial?

The research is being led by Dr Yaacov Lawrence at the Sheba Medical Center, Israel.

The research is primarily funded by Gateway for Cancer Research, a non-profit organization committed to funding innovative cancer research studies that help today's cancer patients feel better, live longer and conquer cancer TODAY! The Israeli Cancer Association is also providing support.

The study has been approved by the ethic board of each participating hospital.

Dr Yaacov Lawrence MA MBBS MRCP graduated from Cambridge University and University College Hospital, London. He is board certified in Internal Medicine and Radiation Oncology.

Between 2007-2010 he was a Fellow and subsequently Attending Physician at Thomas Jefferson University, Philadelphia.

In 2009 he was awarded an ASCO Young Investigator Award. Currently Dr Lawrence leads the Gastro-intestinal program within the Department of Radiation Oncology, Sheba Medical Center and heads the Research Division within the department.

He is a Senior Lecturer at Tel Aviv University. He has received funding from the Israel Cancer Association, the Israel Science Foundation, Israel Cancer Research Fund, NATO, European Union FP7 program, NATO, the Rosetree’s foundation, Pharmaceutical companies, and Gateway for Cancer Research.

How can I participate?

The study is currently open at 8 medical centers around the world. 

  • Toronto, Canada
  • NY, NY USA
  • Columbus, OH USA
  • Tel-Aviv, Israel
  • Gliwice, Poland
  • Porto, Portugal

Further information:

What is celiac plexus radiosurgery?

Israel
New York
Portugal
Toronto
Poland
Ohio

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