Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.

Detailed Description
-----------------
Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile's group. All cCRs were treated with watch and wait. Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.

Official Title
-----------------
Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients: A Case-matched Study

Conditions
-----------------
Almost-cCR, Surgery, Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: transanal surgery
* Procedure: Miles surgery
* Drug: Preoperative chemoradiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histology is confirmed as rectal adenocarcinoma. 18 to 75 years old. Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）. The anus couldn't be retained after TME. Almost-cCR or cCR recurrence during observation. Exclusion Criteria: Patients were unable to tolerate the operation. Preoperative stage: T4b or progress during the treatment. HIV infection stage or chronic hepatitis B. Active clinical severe infections. Evil liquid state or decompensation of organ function. Other malignant tumor history in five years. Other primary carcinoma. Unstable condition and incompliance of the patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: transanal surgery<br>To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm. The intestinal wall was sutured to ensure the integrity of the bowel. | Procedure: transanal surgery<br>* Transanal surgery could Preserve anus to reduce trauma and improve the quality of life<br>Drug: Preoperative chemoradiotherapy<br>* After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.<br>|
| Placebo Comparator: Miles surgery<br>According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed. | Procedure: Miles surgery<br>* Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.<br>Drug: Preoperative chemoradiotherapy<br>* After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | The progression-free survival of 3 years | three years | 
| OS | 3 years of overall survival time | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carcinoembryonic antigen（CEA） | The level of carcinoembryonic antigen in blood | every 3 months,for 2 years | 
| carbohydrate antigen 19-9（CA-199） | The level of carbohydrate antigen 19-9 in blood | every 3 months,for 2 years | 
| International Index of Erectile Function-15 | Describe the function of Erectile ,only for male patients | every 3 months ,for 2 years | 
| International prostate symptom score | Describe the function of prostate,only for male patients | every 3 months ,for 2 years | 
| Female sexual function index | Describe the function of sexual for female patients | every 3 months,for 2 years | 
| Wexner incontinence score | Describe the degree of Anus incontinence | every 3 months,for 2 years | 
| QOL | Describe the quality of life for tumor patients | every 3 months,for 2 years |