A Phase-II Clinical Trial of Radiotherapy to the Coeliac Plexus to Help Pain in Advanced Pancreatic Cancer

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT07689955
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMRT — RADIATION
    IMRT to the Coeliac Plexus for pain management

Study Details

Pain from advanced pancreatic cancer is often difficult to control. This pain commonly occurs when the cancer affects a network of nerves in the abdomen called the coeliac plexus. Even strong pain medicines, including morphine and related drugs, may not give enough relief. Some patients may have a procedure called a coeliac plexus block, but this is invasive, not widely available, and does not always work. Radiotherapy is widely used to relieve cancer-related pain in other cancers, but it is not commonly used in the UK for pancreatic cancer pain. Studies carried out in the United States and Amsterdam have investigated the use of radiotherapy to help control pain in pancreatic cancer and have shown benefit for many patients. However, these studies were not specifically designed to target the coeliac plexus nerve region, which is thought to be an important source of pain in pancreatic cancer. Recent research suggests that radiotherapy directed at this nerve area may reduce pain in many patients with limited side effects. This study is therefore being carried out to investigate whether targeting this nerve area using a short course of radiotherapy can safely and effectively improve pain control in patients with advanced pancreatic cancer. The radiotherapy in this study will be delivered using a widely available technique called Intensity Modulated Radiotherapy (IMRT). IMRT is an advanced form of radiotherapy that allows radiation beams to be shaped very precisely to the treatment area while reducing radiation exposure to nearby healthy tissues and organs. IMRT is routinely used in the NHS to treat many different types of cancer, including prostate, head and neck, lung, and gastrointestinal cancers. In this study radiotherapy is not being given with the intention of treating the cancer itself, but rather to help alleviate pain related to the cancer. The main outcome we will measure is whether pain improves by a meaningful amount using a questionnaire called the Brief Pain Inventory (BPI), which assesses pain severity and its impact on daily life. We will also measure changes in pain medication, treatment side effects, overall survival and patients' overall impression of change after treatment. Participants will be followed up for up to 12 months after radiotherapy treatment. If this study shows a promising signal of benefit, radiotherapy for pancreatic cancer pain could become more widely used across the UK. Because IMRT is available at most radiotherapy centres, many patients could receive treatment closer to home.

Key Dates

First listed
Jul 8, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2031

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Radiotherapy Arm
    Participants receiving IMRT to the Coeliac Plexus

Primary Outcome Measure

To assess the clinical benefit of IMRT radiotherapy to the coeliac plexus in achieving a clinically meaningful reduction in participant-reported pain in participants with inoperable advanced pancreatic adenocarcinoma. [ Time Frame: 3 Years ]

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