Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients

NCT ID: NCT05797467

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2033-04-01

Brief Summary

The goal of this clinical trial] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) compared to adjuvant chemotherapy alone.

Conditions

Colorectal Cancer; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combining targeted therapy group

Adjuvant chemotherapy with targeted therapy

Group Type: EXPERIMENTAL

FOLFOX chemotherapy regimens

Intervention Type: DRUG

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Bevacizumab

Intervention Type: DRUG

Targeted therapy regimens are recommended based on gene testing results. For colorectal cancer patients with KRAS/NRAS/BRAF gene mutations, it is recommended to use Bevacizumab in combination with chemotherapy. For right-sided colon cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Bevacizumab. For left-sided colon and rectal cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Cetuximab.When using targeted therapy in combination with chemotherapy, the treatment course should be synchronized with chemotherapy (Bev 5mg/kg iv d1 or Cet 500mg/m2 iv d1).

Single adjuvant chemotherapy group

Adjuvant chemotherapy alone

Group Type: SHAM_COMPARATOR

FOLFOX chemotherapy regimens

Intervention Type: DRUG

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Interventions

FOLFOX chemotherapy regimens

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Intervention Type: DRUG

Bevacizumab

Targeted therapy regimens are recommended based on gene testing results. For colorectal cancer patients with KRAS/NRAS/BRAF gene mutations, it is recommended to use Bevacizumab in combination with chemotherapy. For right-sided colon cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Bevacizumab. For left-sided colon and rectal cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Cetuximab.When using targeted therapy in combination with chemotherapy, the treatment course should be synchronized with chemotherapy (Bev 5mg/kg iv d1 or Cet 500mg/m2 iv d1).

Intervention Type: DRUG

Other Intervention Names

CapeOx regimens; Cetuximab

Eligibility Criteria

Inclusion Criteria

1. Both sexes, aged 18-75 years;

2. Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;

3. ASA grade < IV and/or ECOG performance status score ≤ 2 points;

4. Fully understand and voluntarily sign the informed consent form for this study.

Exclusion Criteria

1. A history of other malignant tumors;

2. Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;

3. Patients allergic to any component in the study;

4. Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;

5. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests;

6. Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;

7. Patients with a history of severe mental illness;

8. Pregnant or lactating women;

9. Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanxin Luo,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yanxin Luo, PhD,MD

Role: primary

luoyx25@mail.sysu.edu.cn

86-13826190263

Yaoyi Huang, BS

Role: backup

huangyy355@mail2.sysu.edu.cn

86-15986423743

Other Identifiers

1010CG(2022)-03

Identifier Type: -

Identifier Source: org_study_id