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

NCT ID: NCT05279612

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-05-31

Brief 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.

Detailed 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.

Conditions

Colon Neoplasm

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Short-term neoadjuvant chemoradiotherapy

Intervention Type: 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.

neadjuvant chemotherapy group

preoperative 3 circle chemotherapy(CapeOX) combined with surgical treatment(CME+D3)

No interventions assigned to this group

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Diagnosis of colon neoplasm
• 18 years to 70 years
• Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2
• ECOGS score≤2
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nan Wang, Doctor

Role: STUDY_DIRECTOR

General Surgery,Tang-Du of Military Medical University

Locations

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

Xi’an, Shanxi, China

Countries

China

Other Identifiers

K202012-12

Identifier Type: -

Identifier Source: org_study_id