In July 2007 the second amendment of the SCRIPT study was approved by the Central Medical Ethical Committee. In the past only patients with preoperative short term radiotherapy could be randomised. Now patients who have received preoperative long term radiotherapy in combination with 5FU based chemotherapy (chemoradiotherapy) can be randomised as well. This amendment was incorporated in the protocol version June 2007. A new quick reference card was outlined, the patient information sheet and the CRFs were adapted. Investigators of the participating centres received the above mentioned documents in October 2007.
Datacenter Heelkunde, K6-R
P.O. Box 9600,
2300 RC LEIDEN,
More information about this trial is available at our members only page.