RecruitingPhase 3NCT05797467

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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

366 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Chemotherapy Effect

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether adding a targeted therapy to standard chemotherapy after surgery improves outcomes for patients with a specific stage of colorectal cancer (T3-4N2, meaning the cancer has grown through the bowel wall and spread to multiple lymph nodes). **You may be eligible if...** - You are between 18 and 75 years old - You have had surgery for colorectal cancer staged as pT3-4N2 (confirmed by pathology) - You have a good performance status (ECOG 2 or less) - You are willing to sign informed consent **You may NOT be eligible if...** - You have a history of other cancers - You have serious liver, kidney, heart, or lung problems that prevent chemotherapy - You are allergic to study medications - You have severe uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFOLFOX chemotherapy regimens

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

DRUGBevacizumab

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).