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

NCT05279612 | Unknown

• 1 other identifier: K202012-12
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Neoplasm

Outcome Measures

Primary Outcomes (1)

• Investigate patients ORR

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

  7 days after surgery

Secondary Outcomes (6)

• neoplasm down-staging status

  one month after surgery

• Investigate operation safety score

  one month after surgery

• local recurrent rate of neoplasm

  2 years after surgery

• Quality of life score

  one month after surgery

• Investigate patience pRR (pathologic response rate)

  7 days after surgery

Study Arms (2)

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).

Radiation: Short-term neoadjuvant chemoradiotherapy

neadjuvant chemotherapy group

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

Interventions

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.

neoadjuvant chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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）

You may qualify if:

• Diagnosis of colon neoplasm
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

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

Xi’an, Shanxi, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Nan Wang, Doctor

  General Surgery,Tang-Du of Military Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: March 15, 2022
• Study Start: October 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: May 31, 2025
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CN (1)