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

May 22, 2023 updated by: Yanxin Luo,MD, Sixth Affiliated Hospital, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

366

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combining targeted therapy group
Adjuvant chemotherapy with targeted therapy
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.
Other Names:
  • CapeOx regimens
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 chemotherapy, the treatment course should be synchronized with chemotherapy (Bev 5mg/kg iv d1 or Cet 500mg/m2 iv d1).
Other Names:
  • Cetuximab
Sham Comparator: Single adjuvant chemotherapy group
Adjuvant chemotherapy alone
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.
Other Names:
  • CapeOx regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years after operation.
5-year disease-free survival
Time Frame: 5 years after operation.
5 years after operation.
median of disease-free survival
Time Frame: 5 years after operation.
5 years after operation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival
Time Frame: 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.
3 years after recruited.
5-year overall survival
Time Frame: 5 years after recruited.
5 years after recruited.
Complications
Time Frame: 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 years after recruited.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2030

Study Completion (Anticipated)

April 1, 2033

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1010CG(2022)-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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