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Not yet recruiting NCT05699746

CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

Phase III Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capecitabine tablets, Oxaliplatin.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Recurrence-free survival [Time frame: 18 months]
Secondary outcome measures (1)
  • Clearance of circulating tumor DNA (ctDNA) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Colorectal cancer confirmed by pathology, and the TNM stage (AJCC v8) is stage I or stage II. Stage II patients have T3 colonic adenocarcinoma with proficient mismatch-repair system (by immunohistochemistry for four mismatch repair proteins MSH1, MSH2, MSH6, and PMS2) and have no the following clinical risk factors: a) less than 12 lymph nodes examined; b) mucinous carcinoma; c) poor differentiation; d) bowel obstruction or perforation; e) lymphatic/vascular invasion, perineural invasion; f) close, indeterminate, uncertain, positive margins
  • ECOG performance status 0-1
  • No neoadjuvant therapy before surgery
  • Appropriate for active surveillance (i.e., no adjuvant chemotherapy) based on current practice patterns or according to the Chinese Society of Clinical Oncology guidelines for Colorectal Cancer (version 2022)
  • No history of other primary cancers in the past 3 years
  • No history of bone marrow, stem cell or organ transplant
  • Blood samples from 7 to 21 days after surgery were tested positive for ctDNA (tested by MinerVa MRD assay)
  • Pregnancy test done within 14 days before randomization must be negative (for women of childbearing potential only)
  • Voluntarily join the study and sign the informed consent document
  • No unstable or any medical condition that affects patient safety and study compliance evaluated by researchers
  • Availability and provision of adequate surgical tumor tissue for molecular diagnostics

Exclusion criteria

  • Patients with multiple primary colorectal cancers
  • Patients with another primary cancer
  • Patients have the following conditions by blood test, or have obvious contraindication in adjuvant chemotherapy:
  • Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation
  • Absolute neutrophil count <1.5×109/L
  • Platelet count < 75×109/L
  • Hemoglobin <90 g/L
  • Aspartate aminotransferase/Alanine aminotransferase >2.5 × upper limit of normal
  • Lactating women
  • Have serious or uncontrolled medical condition that may preclude compliance with the protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Changhai Hospital of Shanghai — Shanghai
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou
  • Second Affiliated Hospital Zhejiang University College of Medicine — Hangzhou
  • The second hospital of Ningbo City — Ningbo

Identifiers

NCT: NCT05699746 · IR2022577

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗