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

NCT05797467 | Recruiting Phase 3 DMC

• 1 other identifier: 1010CG(2022)-03
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Chemotherapy Effect

Outcome Measures

Primary Outcomes (3)

• 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.

• 5-year disease-free survival

  5 years after operation.

• median of disease-free survival

  5 years after operation.

Secondary Outcomes (3)

• 3-year overall survival

  3 years after recruited.

• 5-year overall survival

  5 years after recruited.

• Complications

  5 years after recruited.

Study Arms (2)

Combining targeted therapy group

EXPERIMENTAL

Adjuvant chemotherapy with targeted therapy

Drug: FOLFOX chemotherapy regimens; Drug: Bevacizumab

Single adjuvant chemotherapy group

SHAM COMPARATOR

Adjuvant chemotherapy alone

Drug: FOLFOX chemotherapy regimens

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.

Also known as: CapeOx regimens

Combining targeted therapy group; Single adjuvant chemotherapy group

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).

Also known as: Cetuximab

Combining targeted therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 4, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2033
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CN (1)