NCT01444495

Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Preoperative radiotherapy	Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
PROCEDURE	Surgery	Total mesorectal excision of rectal cancer

Timeline

• Start date: 1999-01-01
• Primary completion: 2008-06-01
• Completion: 2010-12-01
• First posted: 2011-09-30
• Last updated: 2023-02-15

Locations

1 site across 1 country: Poland