Press release posted 20 June 2024
Manchester's internationally acclaimed cancer research centre, The Christie, has treated its first patient with proton beam therapy in a pioneering clinical trial for oligodendroglioma, a rare type of brain tumour.
The patient from Fallowfield in Manchester is the first person in England to have the treatment as part of the APPROACH clinical trial.
Around 350 people each year are diagnosed with oligodendroglioma, and many of those will live with it for many years. The standard treatment involves surgery to remove as much of the tumour as possible, followed by radiotherapy and chemotherapy.
In the UK, the radiotherapy treatment uses photons or X-rays in small doses, usually once daily on weekdays over 6 to 6-and-a-half weeks. This is very effective, although sometimes photon radiotherapy can cause long-term side effects in normal brain tissue.
Neurocognitive issues, including memory problems or difficulty processing information, can develop in the years after the treatment. Around 1 in 2 patients with brain tumours such as oligodendroglioma may have neurocognitive concerns in the long term, but the benefits of treatment far outweigh the risks.
The average (median) age for patients diagnosed with oligodendroglioma is 45, so these patients often have work and caring responsibilities that may be affected by even a small decline in neurocognitive function.
Proton beam therapy is an alternative type of radiotherapy, which is kinder and more precise. It can reduce the dose of radiotherapy delivered to normal brain tissue, including those parts of the brain involved in memory and processing information.
Doctors believe that proton beam therapy may cause fewer neurocognitive problems, but clinical trials are needed to test this. The APPROACH trial will examine whether the lower dose to normal brain tissue possible with proton beam therapy results in fewer long-term side effects.
Radiotherapy passing through the pituitary gland can also affect hormone levels after treatment is completed, and proton beam therapy may reduce the risk of this, which the trial will also assess.
Proton beam therapy uses proton particles rather than X-rays. It is provided at The Christie in Manchester, the first of two NHS high-energy proton beam therapy centres, the other being University College London Hospitals, which is also involved in the trial.
The APPROACH trial aims to recruit 246 patients from as many as 18 recruiting centres. Half of the 246 patients will be randomly allocated to proton therapy, and the other half will get conventional photon radiotherapy. Accommodation will be provided for those travelling long distances to The Christie.
Sarah Scanlan, age 48, has been working as a senior oncology dietitian for the last 7 years at the hospital which treated her brain tumour with proton beam therapy, The Christie.
Following 2 seizures last year, she had an MRI scan in June 2023, and a day later received the devastating news that she had a brain tumour.
"I was in shock at first," said Sarah. "And even though it was thought to be a low-grade tumour, I still felt like I had a ticking time bomb in my head whilst waiting for my treatment plan. They said I would need a craniotomy (surgery to the skull) to remove as much of the tumour as possible. The surgery was done under local anaesthetic at Salford Royal whilst I was awake."
Most of the tumour was removed. It was shown to be an oligodendroglioma, and Sarah was referred to The Christie for follow-up radiotherapy and chemotherapy.
"Initially, it was odd coming in as a patient rather than a staff member," said Sarah. However, my departmental family and my oncology team have been really supportive, and I feel very fortunate to have my treatment here."
Sarah met her oncologist at The Christie later that summer, who explained the options, including the potential to join a clinical trial opening in 2024.
"Through work, I was aware of a previous clinical trial using proton beam therapy for head and neck cancer patients, and when my oncologist explained the possible benefits for longer-term cognitive function of proton beam therapy, I was keen to be involved," said Sarah.
As the residual tumour was very slow growing, Sarah decided to wait for the APPROACH trial to begin, knowing that if she was accepted, there was a 50% chance of being given proton beam therapy.
Sarah said: "I felt extremely lucky to be accepted to the trial, and to find out I was randomly selected to get proton beam therapy was even better news. It was a 50/50 chance, so I felt I had nothing to lose, as either way, I would still be receiving radiotherapy treatment followed by chemotherapy.
"Since working at The Christie, I am very aware of the importance of clinical trials. They are vital as they help inform whether new treatments are more effective than current treatments, or if the new treatment has fewer side effects."
Sarah has now completed 30 sessions of proton beam therapy, every weekday for 6 weeks.
"The proton beam therapy centre at The Christie is modern and spacious with lots of natural light," said Sarah. "It feels very relaxing, and the proton beam therapy team were very welcoming and friendly. The staff seem to have thought of everything, and their care is second to none. I felt totally safe in their hands."
Sarah, who was once a personal chef, is a big foodie and a keen runner. She has completed 2 marathons and plans to run a third for The Christie Charity next year.
Sarah's consultant at The Christie proton centre, Dr Shermaine Pan, added: "Conventional radiotherapy is very safe and effective with excellent outcomes for most patients with an oligodendroglioma tumour, but this trial may show that proton therapy is even better.
"We are excited to be part of the APPROACH trial, which will be keenly watched internationally. We hope that proton beam therapy will reduce the long-term neurocognitive impact of treatment for oligodendroglioma".
Patients on the trial are randomly allocated to receive standard radiotherapy or proton beam therapy. Those with grade 2 tumours will receive 30 treatments. Patients with grade 3 tumours will receive 33 treatments. Both groups of patients will then receive chemotherapy at their home centre about one to two months after their radiotherapy has been completed.
All patients taking part in the trial will be asked to complete a series of neurocognitive function assessments lasting around 60 minutes. These will occur regularly during the first year of the trial and then once a year for the next four years.
The assessments involve performing several simple tasks, such as joining numbered dots in the correct order as quickly as possible and give researchers an idea of how the brain functions in areas such as memory and speed of reactions following treatment.
Patients on the trial will also be asked to complete questionnaires about their quality of life, work and non-work activities, use of healthcare services and health-related expenses resulting from their condition. There will also be regular blood tests and MRI scans at least once a year for five years.
The study also seeks to understand the impact of oligodendroglioma on a patient's primary caregiver via a series of questionnaires.
The APPROACH trial has been organised by the University of Leeds, Clinical Trials Research Unit and Leeds Cancer Centre in conjunction with other cancer centres across the UK. It is funded by the National Institute for Health and Care Research (NIHR). The NHS proton centres – UCLH and The Christie – also provided expert guidance on developing the trial protocol and radiotherapy guidelines and are part of the trial's management group.
The trial is academically co-led by Dr Louise Murray, Yorkshire Cancer Research Associate Professor and Honorary Consultant Clinical Oncologist, and Professor Susan Short, Professor of Neuro-Oncology, both from the University of Leeds's School of Medicine.
Dr Murray said: "Our trial will help us to establish whether proton beam therapy is less damaging to healthy brain tissue around the tumour. Protecting healthy brain tissue may reduce the risk of cognitive problems, like difficulties with memory and processing information, which can have a huge impact on patients' daily life. The trial will provide vital evidence for the most appropriate radiotherapy treatments for patients, giving them the best possible future."
Find out more about the APPROACH clinical trial at ctru.leeds.ac.uk