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

Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Chemotherapy Effect
• Intervention / Treatment: Drug: FOLFOX chemotherapy regimens; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Anticipated): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliate Hospital of Sun Yat-Sen University
      • Contact: Yaoyi Huang, BS; Phone Number: 86-15986423743; Email: huangyy355@mail2.sysu.edu.cn
      • Contact: Yanxin Luo, PhD,MD; Phone Number: 86-13826190263; Email: luoyx25@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combining targeted therapy group; Adjuvant chemotherapy with targeted therapy	Drug: 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.; Other Names: CapeOx regimens; 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).; Other Names: Cetuximab
Sham Comparator: Single adjuvant chemotherapy group; Adjuvant chemotherapy alone	Drug: 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.; Other Names: CapeOx regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease-free survival	disease-free survival (DFS) is defined as the time from the date of surgery for colorectal cancer to the occurrence of tumor recurrence or metastasis, or death from any cause.	3 years after operation.
5-year disease-free survival		5 years after operation.
median of disease-free survival		5 years after operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival	Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.	3 years after recruited.
5-year overall survival		5 years after recruited.
Complications	When evaluating the safety and tolerability of adjuvant therapy, researchers typically assess adverse events (AEs) based on their incidence and severity, and then grade them according to the NCI CTCAE version 5.0. NCI CTCAE 5.0 categorizes AEs into 5 grades based on severity, including grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death).	5 years after recruited.

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): April 1, 2030
• Study Completion (Anticipated): April 1, 2033

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Cetuximab
• Other Study ID Numbers: 1010CG(2022)-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No