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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797467
• Other study ID #: 1010CG(2022)-03
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: April 1, 2033

Study information

• Verified date: May 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: April 1, 2033
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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).

Locations

Country	Name	City	State
China	The Sixth Affiliate Hospital of Sun Yat-Sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival	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.	3 years after operation.
Primary	5-year disease-free survival		5 years after operation.
Primary	median of disease-free survival		5 years after operation.
Secondary	3-year overall survival	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.	3 years after recruited.
Secondary	5-year overall survival		5 years after recruited.
Secondary	Complications	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 years after recruited.