NCT05797467

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2023-04-01
• Primary completion: 2030-04-01
• Completion: 2033-04-01
• First posted: 2023-04-04
• Last updated: 2023-05-24

Locations

1 site across 1 country: China