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
- Phase
- Phase 3
- Intervention
- FOLFOX chemotherapy regimens
- Conditions
- Colorectal Cancer
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- 5-year disease-free survival
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Yanxin Luo,MD
Principal Investigator
Sixth Affiliated Hospital, Sun Yat-sen University
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.
Arms & Interventions
Combining targeted therapy group
Adjuvant chemotherapy with targeted therapy
Intervention: FOLFOX chemotherapy regimens
Combining targeted therapy group
Adjuvant chemotherapy with targeted therapy
Intervention: Bevacizumab
Single adjuvant chemotherapy group
Adjuvant chemotherapy alone
Intervention: FOLFOX chemotherapy regimens
Outcomes
Primary Outcomes
5-year disease-free survival
Time Frame: 5 years after operation.
median of disease-free survival
Time Frame: 5 years after operation.
3-year disease-free survival
Time Frame: 3 years after operation.
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.
Secondary Outcomes
- 3-year overall survival(3 years after recruited.)
- Complications(5 years after recruited.)
- 5-year overall survival(5 years after recruited.)