This morning’s presentation I presented our randomised clinical trial on pre-operative radio-chemotherapy rather than up-front surgery and adjuvant chemotherapy for resectable and borderline resectable pancreatic cancer.
The background of this trial is the circumstantial evidence that is available in the literature that pre-operative radio-chemotherapy might be better than post-operative adjuvant treatment but up to now there have been no randomised clinical trials to make the level 1 evidence for that.
Therefore a number of years we have decided with our pancreatic cancer, the Dutch Pancreatic Cancer Group, to perform this randomised clinical trial which is a full academic study that we did with the sixteen institutes that comprise this Dutch Pancreatic Cancer Group.
Can you tell us about the patient cohort recruited for this trial?
The patient cohort recruited was the patients that are sent to our multidisciplinary clinics with a diagnosis of pancreatic cancer that is resectable or borderline resectable based upon the CT findings, particularly of their vascular involvement of the tumour.
And when it came to the results from the chemoradiation, can you tell us about those?
The results of our trials, I must say, are preliminary because we are still short 26 events for the final results of this study.
But the preliminary results are promising in the sense that all endpoints are positive, are in favour of pre-operative radio-chemotherapy, that is disease free survival, local control, metastasis free survival, also the survival is positive, but this is just not significant at the present time, with a p-value of 0.074.
When can we await further statistical validation?
We will wait for the final analysis when all 176 events have occurred.
We anticipate now that this will be in about half a year from now and then we will do the final analysis and publish the results.