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

Phase 3

Recruiting

• Conditions: Chemotherapy Effect; Colorectal Cancer
• Interventions: Drug: FOLFOX chemotherapy regimens; Drug: Bevacizumab

• Registration Number: NCT05797467
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study Start: 2023-04-01
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24
• Primary Completion: 2030-04-01
• Study Completion: 2033-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

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

Exclusion Criteria

1. A history of other malignant tumors;
2. Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
3. Patients allergic to any component in the study;
4. Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
5. 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;
6. Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
7. Patients with a history of severe mental illness;
8. Pregnant or lactating women;
9. Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single adjuvant chemotherapy group	FOLFOX chemotherapy regimens	Adjuvant chemotherapy alone
Combining targeted therapy group	FOLFOX chemotherapy regimens	Adjuvant chemotherapy with targeted therapy
Combining targeted therapy group	Bevacizumab	Adjuvant chemotherapy with targeted therapy

Primary Outcome Measures

Name	Time	Method
5-year disease-free survival	5 years after operation.
median of disease-free survival	5 years after operation.
3-year disease-free survival	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 Outcome Measures

Name	Time	Method
3-year overall survival	3 years after recruited.	Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
Complications	5 years after recruited.	When evaluating the safety and tolerability of adjuvant therapy, researchers typically assess adverse events (AEs) based on their incidence and severity, and then grade them according to the NCI CTCAE version 5.0. NCI CTCAE 5.0 categorizes AEs into 5 grades based on severity, including grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death).
5-year overall survival	5 years after recruited.

Trial Locations

Locations (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University; 🇨🇳 GuangZhou, Guangdong, China