Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer
The treatment group comprises patients with locally advanced rectal cancer who were operated
on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on
survival has been systematically collected using national census registry. Patients are
qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with
different time interval between radiotherapy and surgery: one subgroup consists of patients
operated on 7-10 days after the end of irradiation, the second subgroup consists of patients
operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and
localization, distal and circumferential resection margins, number of resected lymph nodes.
3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the
tumor before and after preoperative radiotherapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
local and systemic recurrence rate
Rate of local and sytemic recurrences in patients included to the protocol.
Jan Kulig, Prof.
1st Department of General Surgery, Jagiellonian University
Poland: Ministry of Health
Cracow Rectal Cancer Trial