Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Radiation: Preoperative radiotherapy; Procedure: Surgery

• Registration Number: NCT01444495
• Lead Sponsor: Jagiellonian University

Brief 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.

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2008-06
• Study Completion: 2010-12
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• histologically confirmed rectal cancer
• tumor localised in middle or lower rectum
• age > 18 years
• locally advanced cancer

Exclusion Criteria

• previous pelvis radiotherapy
• lack of patient's consent
• lack of possibility to begin radiotherapy during 14 days after inclusion to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long time interval	Surgery	Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.
Short time interval	Surgery	Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.
Short time interval	Preoperative radiotherapy	Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.
Long time interval	Preoperative radiotherapy	Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.

Primary Outcome Measures

Name	Time	Method
local and systemic recurrence rate	5 years	Rate of local and sytemic recurrences in patients included to the protocol.

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	Overall survival and disease specific survival at 5 years follow-up
downstaging of rectal cancer	1 month	Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging
radical resections rate (R0)	1 month	Rate of R0, R1 and R2 procedures according to Hermanek.
sphincter saving (sparing) procedures	1 month	Rate of sphincter saving operations in both arms.

Trial Locations

Locations (1)

First Department of Surgery; 🇵🇱 Krakow, Malopolska, Poland