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Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation

Lisette Nixon · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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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
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