SCALOP-2 V5.0 31Jul2015

• Research type

  Research Study

• Full title

  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

• IRAS ID

  154496

• Contact name

  Somnath Mukherjee

• Contact email

  somnath.mukherjee@oncology.ox.ac.uk

• Sponsor organisation

  University of Oxford Clinical Trials & Research Governance

• Eudract number

  2013-004968-56

• ISRCTN Number

  ISRCTN50083238

• Clinicaltrials.gov Identifier

  NCT02024009

• Duration of Study in the UK

  5 years, 6 months, 2 days

• Research summary

  Research Summary:

  Currently in the UK, either chemotherapy alone or chemotherapy followed by chemoradiotherapy can be used in the management of inoperable pancreatic cancer that has not spread beyond the pancreas. Chemoradiotherapy consists of 25-30 treatments of radiotherapy in combination with chemotherapy. Although this treatment is effective in controlling local symptoms and slowing down the pace of cancer, in most cases it is unable to remove the cancer or shrink it to make it operable. The reasons behind this could be lack of oxygen and lack of blood flow making the tumour resistant to the treatment. This study will investigate whether increasing the radiotherapy dose, or increasing the oxygen and blood supply to the tumour by giving a drug (Nelfinavir), or a combination of both, can improve outcome. We also want to know what the additional toxicities are from such intensive approaches.
  All patients will initially receive 12 weeks of chemotherapy, and those with stable or responding disease will receive further study treatment.
  The study will consist of two stages. In the first stage we aim to find out the right Nelfinavir dose to combine with chemoradiotherapy; this will require up to 27 patients all of whom will receive Nelfinavir together with chemoradiotherapy. In the second stage, we want to find out the benefits of this approach over and above standard treatments and we will recruit approximately 262 patients and allocate them to one of the five following treatment arms:

  Arm A: Nelfinavir with chemoradiotherapy
  Arm B: Chemoradiotherapy (without nelfinavir)
  Arm C: Nelfinavir with chemoradiotherapy (using a higher radiotherapy dose)
  Arm D: Chemoradiotherapy without nelfinavir (using a higher radiotherapy dose)
  Arm E: Chemotherapy (without radiotherapy or nelfinavir)

  This research is funded by Cancer Research UK. Celgene Limited are providing an educational grant and free nab-paclitaxel to support the study.

  Summary of Results:

  : The research team found that having nelfinavir and higher dose radiotherapy didn’t help people with pancreatic cancer live longer.

  Trial design
  This trial was for people with pancreatic cancer that had grown outside of the pancreas but had not spread. This is called stage 3 cancer, or locally advanced cancer.

  Everyone taking part had chemotherapy to begin with. They then went in to 1 of 5 treatment groups (A to E) at random.

  People in the first 4 groups had capecitabine and radiotherapy. Those in groups A and C also had nelfinavir. And those in groups C and D had a higher dose of radiotherapy. People in group E had chemotherapy, but not radiotherapy or nelfinavir.
  Results
  A total of 106 people joined this trial. There were:

  19 people in group A
  26 people in group B
  19 people in group C
  27 people in group D
  15 people in group E

  The researchers looked at several factors including:

  how long it was before the cancer started to grow
  how many people were living, 12 months after joining the trial

  They compared those who had nelfinavir with those who didn’t. And those who had standard dose radiotherapy with those who had higher dose radiotherapy. They found there was very little difference between the groups.

  Researchers measure something called median progression free survival. This means the length of time before the cancer started to grow in half of the people in the trial. This was between 10 and 11 months for all the groups in this trial. And about 7 out of 10 people in all groups were living a year after joining the trial.

  Side effects
  The research team looked at how many people had side effects. But they are not sure yet whether these were caused by the treatment people had. They could have been a coincidence and not related to the treatment. These are called adverse events, rather than side effects.

  Most people taking part had at least 1 adverse event. Many were mild or didn’t last long, but some were more serious. About 3 in 10 patients had a serious adverse event during chemotherapy. And about 1 in 10 people had a serious adverse event during radiotherapy. This was similar in all the groups.

  Conclusion
  The research team concluded that neither a higher dose of radiotherapy or nelfinavir helped people with pancreatic cancer live longer. But even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  15/SC/0103

• Date of REC Opinion

  30 Apr 2015

• REC opinion

  Further Information Favourable Opinion