Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Surgery in Laparoscope for Advanced Colon Cancer

Study Overview
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Brief Summary
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In this study, a randomized controlled trial was conducted on advanced colon cancer patients with preoperative tumor staging T1-4/N1-2/M0 or T4/N0/M0 to determine the effectiveness of preoperative short-term radiotherapy combined with chemotherapy and whether it can effectively reduce the postoperative local recurrence rate, so as to provide better treatment for colon cancer patients and improve the oncological treatment effect of colon cancer.

Detailed Description
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This is prospective,a single-arm, single center, clinical trail study.The patient entered the study after meeting that criteria.The ORR, R0 resection, OS and DFS of patients and neoplasm down-staging status,etc would be compared.

Official Title
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Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Radical Surgery ( CME + D3 ) for Advanced Colon Cancer : Prospective, a Single-arm, Single Central, Clinical Trial Research

Conditions
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Colon Neoplasm

Intervention / Treatment
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* Radiation: Short-term neoadjuvant chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of colon neoplasm 18 years to 70 years Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2 ECOGS score≤2 thoraco-abdomina CT showed no obvious metastasis（The CT of liver and lung show uncertainty tubercle,suggestive performed PET-CT) cT4,cN0-2,M0 radiography Inclusion Criteria（according postoperative enhanced CT or MRI） progress tubercle penetrate peritoneotome base progress tubercle penetrate serous surface of neighboring organ progress tubercle development by late mesentery or side abdominis Exclusion Criteria: Appeared other system cancer Patient with postoperative recurrent of colon cancer Patient with malignancies history in recent 5 years Pregnant or female of suckle period The patient have adjuvant radiotherapy record in other system cancer before this time treatment，and Patient with surgical contraindications. The patient have accepted adjuvant chemoradiotherapy before this time treatment. Distant metastasis found during surgery Patients with poor radiotherapy compliance and difficulty in coordination Patients with mental disorders

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neoadjuvant chemoradiotherapy group<br>preoperative 1 circle chemotherapy(CapeOX) combined with short-course radiotherapy ，Surgical treatment(CME+D3) after four weeks of 2 circle chemotherapy(CapeOX). | Radiation: Short-term neoadjuvant chemoradiotherapy<br>* Short-term radiotherapy ( 25 Gy, 5f ) + XELOX regimen was performed before operation for two cycles. After the condition was evaluated by enhanced CT, whether the patients belonged to PD, SD, PR and CR was analyzed (reference RECIST 1.1). Surgery was performed four weeks after chemotherapy.<br>|
| neadjuvant chemotherapy group<br>preoperative 3 circle chemotherapy(CapeOX) combined with surgical treatment(CME+D3) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate patients ORR | Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response) | 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neoplasm down-staging status | Observation of neoplasm down-staging status in patients according to RECIST 1.1 | one month after surgery | 
| Investigate operation safety score | Operation safety reference Clavien degree of postoperative complication | one month after surgery | 
| local recurrent rate of neoplasm | Observation local recurrent rate of neoplasm in patients | 2 years after surgery | 
| Quality of life score | Investigate postoperative Quality of life in patients after surgery | one month after surgery | 
| Investigate patience pRR (pathologic response rate) | According to the English version of the Japanese Gastric Cancer Classification (JCGC) 3rd edition, pRR is defined as survival of tumor cells remaining in less than 2/3 of the tumor area (level Ib or higher) | 7 days after surgery | 
| R0 resection | R0 resection indicates a microscopically margin-negative resection,in which no gross or microscopic tumor remains in the primary tumor bed | immediately after surgery |