NCT05699746

CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

A Randomized Controlled Trial of CAPEOX vs Observation in Early-stage Colorectal Cancer Patients With Positive MRD After Curative Surgery

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine tablets	Capecitabine 1000 mg/m2, twice daily PO for 14 days, repeat every 3 weeks, for at most 8 cycles.
DRUG	Oxaliplatin	Oxaliplatin 130 mg/m2 IV day 1, combined with Capecitabine, for at most 8 cycles.

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

4 sites across 1 country: China