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

Tang-Du Hospital

Status: Active, not recruiting

Conditions: Colon Neoplasm

Treatments: Radiation: Short-term neoadjuvant chemoradiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05279612

K202012-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

177 participants in 2 patient groups

neoadjuvant chemoradiotherapy group

Description:

preoperative 1 circle chemotherapy(CapeOX) combined with short-course radiotherapy ，Surgical treatment(CME+D3) after four weeks of 2 circle chemotherapy(CapeOX).

Treatment:

Radiation: Short-term neoadjuvant chemoradiotherapy

neadjuvant chemotherapy group

Description:

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