Actively Recruiting
Adjuvant Chemotherapy Combined With Targeted Therapy versus Adjuvant Chemotherapy Alone in Stage T3-4N2 Colorectal Cancer: A Multicenter, Randomized Phase III Clinical Trial
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2023-05-24
366
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two treatment approaches for patients with resectable stage T3-4N2 colorectal cancer. The main goal is to see if combining targeted therapy with standard adjuvant chemotherapy improves disease-free survival compared to chemotherapy alone. This is a Phase III randomized clinical trial sponsored by the Sixth Affiliated Hospital, Sun Yat-sen University. Participants will be assigned to one of two groups: one receiving adjuvant chemotherapy combined with targeted therapy, and the other receiving only adjuvant chemotherapy. Chemotherapy regimens include oxaliplatin-based CapeOx or FOLFOX, single-agent 5-FU/LV, or capecitabine. Targeted therapy, such as Bevacizumab or Cetuximab, is selected based on gene mutation status and is given alongside chemotherapy on specific schedules. During the study, participants will be monitored for outcomes including 3-year and 5-year disease-free survival, median disease-free survival, overall survival, and complications. The study involves long-term follow-up up to five years after surgery to thoroughly assess treatment effects and safety. Participants will undergo regular evaluations as part of this process to track their health and response to treatment.
CONDITIONS
Brief Title
Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both sexes, aged 18-75 years
- Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery
- ASA grade less than IV and/or ECOG performance status score 2 points or lower
- Fully understand and voluntarily sign the informed consent form for this study
You will not qualify if you...
- History of other malignant tumors
- Severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy
- Allergy to any study components
- Severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases
- Other factors affecting study results or causing early study termination such as alcoholism, drug abuse, serious diseases requiring comprehensive treatment, severe lab abnormalities
- Emergency surgery due to intestinal obstruction, perforation, bleeding, etc.
- History of severe mental illness
- Pregnant or lactating women
- Other clinical or laboratory conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration synchronized with chemotherapy cycles as per regimen
Participants receive adjuvant chemotherapy with or without targeted therapy following surgery for colorectal cancer.
Visits according to chemotherapy and targeted therapy schedule
Duration - Up to 5 years after surgery
Participants are monitored for disease-free survival and overall survival outcomes after treatment completion.
Periodic visits for assessments over 5 years
Trial Site Locations
Total: 1 location
1
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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