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NCT Number: NCT05797467

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

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.

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Key information

Conditions

Colorectal Cancer Chemotherapy Effect Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: CapeOx regimens

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).

Other names: Cetuximab

Primary outcomes

  1. 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.

  2. 5-year disease-free survival

    Time frame: 5 years after operation.

  3. median of disease-free survival

    Time frame: 5 years after operation.

Secondary outcomes

  1. 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.

  2. 5-year overall survival

    Time frame: 5 years after recruited.

  3. 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).

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2030
Study completion
2033
First posted
Apr 4, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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