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

Tang-Du Hospital177 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

177

Conditions

Colon Neoplasm

Interventions

Short-term neoadjuvant chemoradiotherapyRADIATION

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University

Xi’an, Shanxi, China

Outcomes

Primary Outcomes

Investigate patients ORR

Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response)

Time frame: 7 days after surgery

Secondary Outcomes

neoplasm down-staging status

Observation of neoplasm down-staging status in patients according to RECIST 1.1

Time frame: one month after surgery

Investigate operation safety score

Operation safety reference Clavien degree of postoperative complication

Time frame: one month after surgery

local recurrent rate of neoplasm

Observation local recurrent rate of neoplasm in patients

Time frame: 2 years after surgery

Quality of life score

Investigate postoperative Quality of life in patients after surgery

Time frame: 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)

Time frame: 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

Time frame: immediately after surgery

Data from ClinicalTrials.gov

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