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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT05797467
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX chemotherapy regimens — DRUG
    Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
  • Bevacizumab — 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).

Study Details

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.

Key Dates

First listed
Apr 4, 2023
Start date
Apr 1, 2023
Status verified
May 2023
Primary completion
Apr 1, 2030
Completion
Apr 1, 2033

Study Design

Enrollment
366 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combining targeted therapy group
    Adjuvant chemotherapy with targeted therapy
  • Sham Comparator: Single adjuvant chemotherapy group
    Adjuvant chemotherapy alone

Primary Outcome Measure

3-year disease-free survival [ Time Frame: 3 years after operation. ]

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