SCOPE2

SCOPE2 is investigating the effects of a higher than normal dose of radiotherapy and a different type of chemotherapy to treat cancer of the food pipe (oesophagus).

Background

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 in-operable tumour of the oesophagus.

It is for people with oesophageal cancer:

  • who cannot have surgery
  • having chemotherapy and radiotherapy together (chemoradiotherapy).

In this trial people have one of the following:

  • high dose radiotherapy
  • normal (standard) dose radiotherapy.

Doctors usually give a combination of two chemotherapy drugs together with radiotherapy. They often use cisplatin and capecitabine. Sometimes, people are unable to have capecitabine and a drug called fluorouracil is used instead. But the standard treatment does not always work. So, doctors want to see if changing to carboplatin and paclitaxel is a more effective course of treatment in some patients.

Study aims

The main aims of this study are to:

  • find out if having a higher dose of radiotherapy is better at killing cancer cells
  • find out if changing to carboplatin and paclitaxel is better in some patients
  • learn about the side effects and how people cope with them
  • find out how people feel about the new treatment
  • find out what happens to the chemotherapy in your body
  • find out if it is possible to do a larger study using higher dose radiotherapy and the new chemotherapy combination.

Study design

Prior to the commencement of treatment each patient will have a special scan called a PET scan. Patients will receive a second PET scan two weeks after the start of standard chemotherapy. The changes between the two scans will then be used to allocate treatment into the different arms of the study. All study subjects will be randomised to receive either the standard radiotherapy dose or the high radiotherapy dose. The participants who do not respond to the first cycle of standard chemotherapy will be eligible to take part in the aspect of the trial looking at an alternative chemotherapy regimen.

Randomisation process

Patients will be randomised as follows:

On the basis of the second PET scan, patients who are not responding to standard chemotherapy will be allocated by a computer to one of the four groups:

  • standard chemotherapy and standard dose of radiotherapy
  • standard chemotherapy and higher dose of radiotherapy
  • alternative chemotherapy and standard dose of radiotherapy
  • alternative chemotherapy and higher dose of radiotherapy.

Patients who are responding to standard chemotherapy (or where the response is unknown or those who were not eligible for PET scan portion of the study) will be allocated by a computer to one of two groups:

  • standard chemotherapy and standard dose of radiotherapy
  • standard chemotherapy and higher dose of radiotherapy.

The arms within each of the groups above (responders and non-responders) will be equal in size and patients will be allocated randomly by a computer.

Information

Chief Investigator(s)
Funder(s) Cancer Research UK
Sponsor Velindre NHS Trust

Key facts

Start date 1 Jan 2015
End date 1 Dec 2023
Grant value £1,682,836
Status
  • Recruiting

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