|The aim of this research study is to compare and evaluate two established treatments for oesophageal cancer in order to establish if one treatment is superior to the other. The research group believe it is not currently clear which regimen is of greatest benefit to patients. These 2 regimens have been tested in previous randomised trials (MAGIC & CROSS).
The 2 treatments are either chemotherapy before and after surgery, or chemotherapy with radiotherapy before surgery. Both treatments are standard and have been in use as treatments for oesophageal cancer for several years. 594 patients with oesophageal and oesophagogastric junction cancer will be randomly allocated to these 2 treatments. During the trial patients will have a variety of clinical assessments and will complete health-related questionnaires.
Following objectives are patient quality of life, complications and relief of swallowing problems.
|This study will evaluate whether increasing the dose of radiotherapy and/or the addition of nelfinavir to the chemotherapy increases the progression free survival in patients with inoperable cancer of the pancreas that has not spread beyond the pancreas.
The study consists of 2 stages:
Stage 1 – to determine the safe, tolerable dose of nelfinavir to be administered alongside chemoradiotherapy. This will establish the dose of nelfinavir to be taken forward to stage 2.
This will identify an optimum dose of oral nelfinavir in comnbination with capecitabine during radiotherapy, following 4 cycles of GEMABX.
Endpoint – a safe and tolerable dose of nelfinavir to be administered alongside chemoradiotherapy.
1. Does increasing the radiotherapy does schedule improve the 12 months survival rate?
2. Does the addition of nelfinavir to CRT improve progression free survival?
All patients revieve three cycles of GEMABX. Those without progression disease will then be randomised to one of the following arms.
Arm A: Nelfinavir together with chemoradiotherapy
Arm B: Chemoradiotherapy (without nelfinavir)
Arm C: Nelfinavir together with chemoradiotherapy (but using a higher dose of radiotherapy) – this involves 2 more fractions
Arm D: Chemoradiotherapy without nelfinavir (but using a higher dose of radiotherapy) this involves 2 more fractions
Arm E: Chemotherapy alone
Patients not eligible for the study will be treated as per local standard but will be followed up on the study.
Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers