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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemoradiotherapy group | preoperative 1 circle chemotherapy(CapeOX) combined with short-course radiotherapy ，Surgical treatment(CME+D3) after four weeks of 2 circle chemotherapy(CapeOX). |
| |
| neadjuvant chemotherapy group | preoperative 3 circle chemotherapy(CapeOX) combined with surgical treatment(CME+D3) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-term neoadjuvant chemoradiotherapy | Radiation | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Diagnosis of colon neoplasm, 18 years to 70 years, Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2, 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）
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| Name | Affiliation | Role |
|---|---|---|
| Nan Wang, Doctor | General Surgery,Tang-Du of Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University | Xi’an | Shanxi | China |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |