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In commemoration of World Cancer Day on 4 February 2016, we are pleased to announce the opening of a new Cancer Research UK-funded pancreatic cancer trial supported by CSM statisticians.

A high-dose SCALOP-2 radiotherapy treatment plan. A higher-than-standard radiotherapy dose to the tumour (red outline) will be tested in the study Virdee et al., 2015
A high-dose SCALOP-2 radiotherapy treatment plan. A higher-than-standard radiotherapy dose to the tumour (red outline) will be tested in the study

A new trial called SCALOP-2 (Systemic therapy and Chemoradiation in Advanced LOcalised Pancreatic cancer-2) starting this month in Oxford will investigate whether particular chemotherapy and chemoradiotherapy treatments can improve outcomes for patients with locally advanced inoperable pancreatic cancer that has not spread beyond the pancreas. The trial is led by the Oxford Clinical Trials Research Unit with statistics support from the Centre for Statistics in Medicine (CSM). SCALOP-2 has the potential to change the standard of care for this group of pancreatic cancer patients.

“Pancreatic cancer has one of the poorest outcomes amongst cancers and survival across the world has remained unaltered for decades. We desperately require a breakthrough to treat this cancer, and novel approaches, alongside both chemotherapy and radiotherapy, need to be tested. The UK has demonstrated its ability to deliver high quality multi-centre pancreatic radiation trials through SCALOP, and we hope that SCALOP-2 will further refine management of this condition” said Dr Somnath Mukherjee, based at the CRUK/MRC Oxford Institute for Radiation Oncology, who is the Chief Investigator for this study.

Pancreatic tumours that cannot be removed surgically but have not spread beyond the pancreas are usually treated in the UK with chemotherapy alone or chemotherapy followed by chemoradiation. These treatments control symptoms, but usually do not eradicate the cancer or shrink the tumours enough to allow surgical removal. Lack of oxygen and lack of adequate blood flow both contribute to this treatment resistance.

We desperately require a breakthrough to treat [pancreatic] cancer, and novel approaches, alongside both chemotherapy and radiotherapy, need to be tested - Somnath Mukherjee

The drug nelfinavir improved oxygenation and blood supply in pre-clinical studies. SCALOP-2 will investigate whether this drug, when used during chemoradiotherapy, can make pancreatic tumours more sensitive to chemotherapy and radiotherapy treatments. SCALOP-2 will also investigate whether a higher dose of radiotherapy can improve outcomes.

SCALOP-2 will be the largest chemoradiotherapy trial for pancreatic cancer in the UK. The first stage of the trial will identify a safe dose of nelfinavir that can be used together with chemoradiotherapy. The second stage is a phase II, multi-centre randomised study investigating whether increasing the dose of radiotherapy, adding nelfinavir, or a combination of the two will prolong survival in patients with locally advanced inoperable pancreatic cancer that has not spread beyond the pancreas. Trial participants will receive 4 months of gemcitabine and nab-paclitaxel (Abraxane) chemotherapy. Participants with non-progressing disease will then continue with chemotherapy, with added radiotherapy. They will be randomly allocated to receiving either a standard or higher dose of radiotherapy and to either receiving or not receiving nelfinavir with their chemoradiotherapy.

Pradeep Virdee cancer research quote

Recruitment to stage 1 of the trial will be starting soon at the Churchill Hospital, Oxford, with another ten cancer centres across the UK planned to open later: Addenbrookes Hospital, Bristol Haematology and Oncology Centre, Castle Hill Cancer Centre, Churchill Hospital, Hammersmith Hospital, Royal Free Hospital, Royal Surrey County Hospital, St James’ University Hospital, University College Hospital, University Hospital Coventry, Velindre Cancer Centre. Stage 2 will open in a larger number of radiotherapy centres across the UK, still to be finalised.

This news item is part of a series on the cancer research conducted and supported by the Centre for Statistics in Medicine, in commemoration of World Cancer Day on 4 February 2016. Read the introduction to the series here, about two trials on Barrett's Oesophagus here, and about a little-used trial design that will improve the efficiency of phase I trials here.

SCALOP-2 details:

Funding by the Clinical Trials Advisory and Awards Committee on behalf of Cancer Research UK [grant number C28958/A17139]. Application title: CRUK/07/040: SCALOP-2. Free of charge nab-paclitaxel and an educational grant to support the study provided by Celgene Ltd. Radiotherapy trials quality assurance provided by the National Radiotherapy Trials Quality Assurance Team. Sponsored by the University of Oxford. Trial management by the Oncology Clinical Trials Office (OCTO) and statistical input by CSM, both part of Oxford Clinical Research Unit, a UKCRC- and NCRI-registered clinical trials unit. ClinicalTrials.gov number: NCT02024009. EudraCT number: 2013-004968-56.

Image attribution: Virdee P, Mukherjee S, Ward E, et al. (2015, 1 November). A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/- nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer. Poster presented at the Annual NCRI Conference in Liverpool, UK.