Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.

Detailed Description
-----------------
The study plans to recruit 100 patients,randomized into study group and control group,patients in study group are given the dose of PTV(planned target volume)-CTV(clinical target volume) 25Gy/5F with a local boost of PTV-GTV(gross tumour volume) 30Gy/5F；patients in control group are given the dose of PTV-CTV 25Gy/5F without a local boost. The other inventions are the same during the whole treatment,after the radiotherapy,they will receive a surgery under TME((total mesorectal excision) principal.Comparing the toxicity of radiotherapy, R0 resection rate,pathological complete remission rate, complications of operation and sphincter retention rate of these two groups to find out weather local boost bringing benefits to patients with local advanced rectal cancer.

Official Title
-----------------
Preoperative Short-course Radiotherapy With Local Boost Versus Conventional Preoperative Short-course Radiotherapy for Rectal Cancer

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

Intervention / Treatment
-----------------
* Radiation: preoperative short-course radiotherapy with local boost
* Radiation: preoperative short-course radiotherapy without local boost
* Procedure: TME surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Local advanced rectal cancer (TNM Stage ：T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography . distance between tumour and anal edge ≤12cm. PS（(Performance Status） score 0-2 or Karnofsky score≥70. liver and kidney functions are normal. without any treatment before inclusion. Exclusion Criteria: metastasis combined with other severe diseases，such as other kind of cancer ,COPD,myocardial infarction,ect. include in other clinical trails.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Preoperative short-course radiotherapy with local boost ,the dose of radiotherapy is PTV-CTV 25Gy/5F with local boost of PTV-GTV 30Gy/5F. TME surgery after radiotherapy. | Radiation: preoperative short-course radiotherapy with local boost<br>* Except the clinical target volume(CTV),a gross tumour volume（GTV）is delineated，and give a dose of PTV-GTV:30Gy/5F<br>Procedure: TME surgery<br>* both study group and control group received surgery under TME principle after radiotherapy<br>|
| Active Comparator: control group<br>Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost. TME surgery after radiotherapy. | Radiation: preoperative short-course radiotherapy without local boost<br>* Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F<br>Procedure: TME surgery<br>* both study group and control group received surgery under TME principle after radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete remission rate |  | 4 weeks after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | From date of randomization until the date of first documented progression，assessed up to 60 months | 
| sphincter retention rate |  | 4 weeks after the surgery | 
| toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events，CTCAE v3.0) |  | up to 60 months |