NCT05699746Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 26 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 16 Jan 2023
- Start date
- Mar 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- Zhejiang University
- Diseases
- Colorectal cancer
- NCT number
- NCT05699746
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 38
- From Mar 2023 to the primary completion date, Sept 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with multiple primary colorectal cancers
- Patients with another primary cancer
- Have serious or uncontrolled medical condition that may preclude compliance with the protocol
Lab values
- 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
Other
- Lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital Zhejiang University College of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The second hospital of Ningbo City Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Changhai Hospital of Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.