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CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD
Sponsor: Zhejiang University
Summary
Patients with stage Ⅰ colorectal cancer or stage Ⅱ colon cancer usually have a good prognosis and are not recommended to receive adjuvant chemotherapy after radical surgery. With the advances in liquid biopsy technology, detection of circulating tumor DNA (ctDNA) can effectively identify early-stage cancer patients with minimal residual disease (MRD) after surgery. According to the growing number of MRD studies in solid tumor, colorectal cancer patients with ctDNA-MRD detection have a poor clinical outcome and are likely to relapse within two years. This study aims to assess the efficacy of adjuvant chemotherapy with capecitabine plus oxaliplatin (CAPEOX) compared with conventional observation in MRD-positive patients with stage I colorectal cancer and clinically low-risk stage II colon cancer.
Official title: A Randomized Controlled Trial of CAPEOX vs Observation in Early-stage Colorectal Cancer Patients With Positive MRD After Curative Surgery
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2023-03
Completion Date
2026-12
Last Updated
2023-01-26
Healthy Volunteers
No
Conditions
Interventions
Capecitabine tablets
Capecitabine 1000 mg/m2, twice daily PO for 14 days, repeat every 3 weeks, for at most 8 cycles.
Oxaliplatin
Oxaliplatin 130 mg/m2 IV day 1, combined with Capecitabine, for at most 8 cycles.
Locations (4)
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, China
The second hospital of Ningbo City
Ningbo, Zhejiang, China