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Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Clinical Trial Summary

The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01444495
Study type Interventional
Source Jagiellonian University
Contact
Status Completed
Phase N/A
Start date January 1999
Completion date December 2010
View Details
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