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

Colon Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05279612
• Other study ID #: K202012-12
• Status: Active, not recruiting
• Start date: October 1, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2022
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: May 31, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Neoplasm
• Colonic Neoplasms

Intervention

Radiation:
• Short-term neoadjuvant chemoradiotherapy
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.

Locations

Country	Name	City	State
China	General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate patients ORR	Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response)	7 days after surgery
Secondary	neoplasm down-staging status	Observation of neoplasm down-staging status in patients according to RECIST 1.1	one month after surgery
Secondary	Investigate operation safety score	Operation safety reference Clavien degree of postoperative complication	one month after surgery
Secondary	local recurrent rate of neoplasm	Observation local recurrent rate of neoplasm in patients	2 years after surgery
Secondary	Quality of life score	Investigate postoperative Quality of life in patients after surgery	one month after surgery
Secondary	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
Secondary	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