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Recruiting NCT05797467

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

Phase III Interventional Colorectal Cancer Chemotherapy Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FOLFOX chemotherapy regimens, Bevacizumab.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Chemotherapy Effect. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 chemothe

Primary outcome measures

  • 3-year disease-free survival [Time frame: 3 years after operation.]
  • 5-year disease-free survival [Time frame: 5 years after operation.]
  • median of disease-free survival [Time frame: 5 years after operation.]
Secondary outcome measures (3)
  • 3-year overall survival [Time frame: 3 years after recruited.]
  • 5-year overall survival [Time frame: 5 years after recruited.]
  • Complications [Time frame: 5 years after recruited.]

Eligibility criteria

Inclusion criteria

  • Both sexes, aged 18-75 years;
  • Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
  • ASA grade < IV and/or ECOG performance status score ≤ 2 points;
  • Fully understand and voluntarily sign the informed consent form for this study.

Exclusion criteria

  • A history of other malignant tumors;
  • Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
  • Patients allergic to any component in the study;
  • Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
  • 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;
  • Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
  • Patients with a history of severe mental illness;
  • Pregnant or lactating women;
  • Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT05797467 · 1010CG(2022)-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗