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NOT YET RECRUITING
NCT05699746
PHASE3

CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

Sponsor: Zhejiang University

View on ClinicalTrials.gov

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

Interventions

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.

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