Oesophageal Cancer Clinical Trial
Official title:
SCOPE2 - 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)
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 tumour of the oesophagus. This trial will compare the effects of the standard
dose of radiotherapy to a higher dose whilst closely monitoring the side effects.
A comparison will also be made regarding the effects of the standard drugs used in
chemotherapy (cisplatin and capecitabine) with an alternative combination (carboplatin and
paclitaxel) in patients that do not show a response to chemotherapy with standard drugs early
on in treatment.
All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy.
How the study will be conducted:
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 that 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. 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 detailed below:
- 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 detailed below:
- 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.
This study will also compare the way that this treatment affects the two different cell types
found in oesophageal tumours.
The effects of the different treatment, together with the costs of the different treatment
and the effects on quality of life will be analysed to see which is more effective for each
of the different groups.
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