SCOPE 2

• Research type

  Research Study

• Full title

  A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemo-radiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET)

• IRAS ID

  169633

• Contact name

  Tom Crosby

• Contact email

  Tom.Crosby@wales.nhs.uk

• Sponsor organisation

  Velindre NHS Trust

• Eudract number

  2015-001740-11

• Duration of Study in the UK

  8 years, 0 months, 1 days

• Research summary

  SCOPE 2 (Study of Chemoradiotherapy in Oesophageal cancer with PET and dose Escalation) is a CRUK funded trial recruiting patients across the UK with oesophageal cancer. This trial aims to answer two important questions;

  1) Does increasing the dose of radiotherapy improve patient outcomes? Research has shown that increasing the dose of radiotherapy improves outcomes in patients with lung and head and neck cancers. This study aims to see whether this is also the case for patients with oesophageal cancer.
  
  2) Additionally, we also want to find out whether patients may benefit from receiving a different type of chemotherapy if they do not show an early response to standard chemotherapy drugs.

  How will the study be conducted?
  Patients recruited onto the trial will receive 3 weeks of standard chemotherapy followed by a PET (positron emission tomography) scan at day 14 to see how the tumour is responding to the chemotherapy. The PET scan results will determine which treatment will be available to patients.

  All patients will be randomized to receive either;
  • Standard dose radiotherapy
  • High dose radiotherapy

  If the PET scan shows that the tumour has not shown much of a change in response to chemotherapy, then patients may receive different chemotherapy drugs with their radiotherapy.

  All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy. Patients will be followed up for
  a minimum of 2 years.

  The patient outcomes, the effect of the treatment on the quality of life of the patients and the economic considerations within the different arms will be compared. The trial will also explore patient experiences and perceptions of treatments and taking part in the trial, through qualitative approaches.

• REC name

  Wales REC 3

• REC reference

  15/WA/0395

• Date of REC Opinion

  22 Jan 2016

• REC opinion

  Further Information Favourable Opinion