Clinical trial NCT05699746: CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD
Official title: A Randomized Controlled Trial of CAPEOX vs Observation in Early-stage Colorectal Cancer Patients With Positive MRD After Curative Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: GeneCast Biotechnology Co., Ltd.
First posted: 2023-01-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. ECOG performance status 0-1
3. No neoadjuvant therapy before surgery
4. 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)
5. No history of other primary cancers in the past 3 years
6. No history of bone marrow, stem cell or organ transplant
7. Blood samples from 7 to 21 days after surgery were tested positive for ctDNA (tested by MinerVa MRD assay)
8. Pregnancy test done within 14 days before randomization must be negative (for women of childbearing potential only)
9. Voluntarily join the study and sign the informed consent document
10. No unstable or any medical condition that affects patient safety and study compliance evaluated by researchers
11. Availability and provision of adequate surgical tumor tissue for molecular diagnostics

Exclusion Criteria:

1. Patients with multiple primary colorectal cancers
2. Patients with another primary cancer
3. Patients have the following conditions by blood test, or have obvious contraindication in adjuvant chemotherapy:

   1. Moderate/severe renal impairment (GFR\<30 ml/min), as calculated by the Cockcroft and Gault equation
   2. Absolute neutrophil count \<1.5×109/L
   3. Platelet count \< 75×109/L
   4. Hemoglobin \<90 g/L
   5. Aspartate aminotransferase/Alanine aminotransferase \>2.5 × upper limit of normal
4. Lactating women
5. Have serious or uncontrolled medical condition that may preclude compliance with the protocol

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 18 months
Secondary outcomes:
measure: Clearance of circulating tumor DNA (ctDNA)
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The second hospital of Ningbo City
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Kefeng Ding, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: