Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Study Overview
=================
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.

Official Title
-----------------
Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Radiation: Preoperative radiotherapy
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short time interval<br>Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy. | Radiation: Preoperative radiotherapy<br>* Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)<br>* Other names: Neoadjuvant radiotherapy;Procedure: Surgery<br>* Total mesorectal excision of rectal cancer<br>* Other names: Operative treatment;|
| Experimental: Long time interval<br>Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy. | Radiation: Preoperative radiotherapy<br>* Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)<br>* Other names: Neoadjuvant radiotherapy;Procedure: Surgery<br>* Total mesorectal excision of rectal cancer<br>* Other names: Operative treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local and systemic recurrence rate | Rate of local and sytemic recurrences in patients included to the protocol. | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, radiotherapy, overall survival, recurrence rate, downstaging