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Trial Title:
Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
NCT ID:
NCT05797467
Condition:
Colorectal Cancer
Chemotherapy Effect
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Cetuximab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FOLFOX chemotherapy regimens
Description:
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or
single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Arm group label:
Combining targeted therapy group
Arm group label:
Single adjuvant chemotherapy group
Other name:
CapeOx regimens
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
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).
Arm group label:
Combining targeted therapy group
Other name:
Cetuximab
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Sixth Affiliate Hospital of Sun Yat-Sen University
Address:
City:
GuangZhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanxin Luo, PhD,MD
Phone:
86-13826190263
Email:
luoyx25@mail.sysu.edu.cn
Contact backup:
Last name:
Yaoyi Huang, BS
Phone:
86-15986423743
Email:
huangyy355@mail2.sysu.edu.cn
Start date:
April 1, 2023
Completion date:
April 1, 2033
Lead sponsor:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Source:
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797467
